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出境医 / 临床实验 / Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain

Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain

Study Description
Brief Summary:

Chronic knee pain from osteoarthritis (OA) is commonly treated with total knee arthroplasty (TKA) when conservative therapies fail to provide pain relief. More than 600,000 TKAs are performed in the U.S. annually, a number that continues to increase. A logistic-regression model suggests that the incidence rate of TKA will increase by 143% in the United States by 2050 compared to 2012. Although TKA is successful in reducing knee pain and joint stiffness in most cases, it can be associated with a 7-35% incidence of persistent refractory post-surgical knee pain.

Aim:

To determine whether chemical neurolysis of the genicular nerves with 6% aqueous phenol is non-inferior in reducing knee pain as compared to corticosteroid injection of the genicular nerves, in patients with refractory chronic knee pain for more than 6 months after total knee replacement.

Hypothesis:

Chemical neurolysis of genicular nerves with phenol will provide equal or superior pain relief than corticosteroid genicular nerve injections at 3 months, as measured by the Oxford Knee Score.


Condition or disease Intervention/treatment Phase
Pain, Chronic Drug: Phenol Injection Drug: Methylprednisolone Injection Phase 4

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A Pilot Prospective, Randomized, Crossover Trial. (Block randomization scheme with 2:1 allocation (phenol neurolysis : perineural steroid injection) The crossover will occur in subjects who received the steroid injection who did not achieve adequate pain relief at 3 months.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain Following Total Knee Arthroplasty: a Pilot Prospective, Randomized, Crossover Trial
Actual Study Start Date : May 24, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : March 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Treatment Group: Phenol injection
6% aqueous phenol 2.5 mL will be mixed with 0.5 mL iopamidol 300 and will be injected at each target sites
 Drug: Phenol Injection
6% aqueous phenol 2.5 mL will be mixed with 0.5 mL iopamidol 300 and will be injected at each target site with live, pulsed fluoroscopy (5-8 seconds at each location) to observe the contrast dye-tagged phenol covering the lateral margin of the femur or tibia respectively on AP and lateral views. The needles will then be removed and band-aids placed.
Other Name: Phenol
Control Group: Methylprednisolone injection
Methylprednisolone acetate 10 mg with 2 mL preservative free saline and 0.5 mL iopamidol 300 will be injected at each of the target site
 Drug: Methylprednisolone Injection
Methylprednisolone acetate 10 mg with 2 mL preservative saline and 0.5 mL iopamidol 300 will be injected at each of the 3 target sites with live, pulsed fluoroscopy (5-8 seconds at each location) to observe the contrast dye-tagged steroid mixture covering the lateral margin of the femur or tibia respectively on AP and lateral views; the needles will be removed and band-aids placed.
Other Name: Methylprednisolone acetate
Outcome Measures
Primary Outcome Measures :
  1. Oxford Knee Score [ Time Frame: 3 months ]
    Oxford Knee Score is a tool which measures 6 post operative items (pain,flexion contracture, extension lag, total range of flexion, alignment of varus and valgus,stability (antero-posterior and mediolateral). The scoring is: below 60 is poor, scoring 60-69 fair, scoring 70-79 good, 80-100 excellent.


Secondary Outcome Measures :
  1. Numeric Rating Scale Score [ Time Frame: 3months ]
    The proportion of subjects who have > 50% reduction in pain based on the Numeric Rating Scale at 3 months. The NRS is a scale of 0 (no pain) to 10 (worst pain imaginable)

  2. Numeric Rating Scale Score [ Time Frame: 6 months ]
    The proportion of subjects who have > 50% reduction in pain based on the Numeric Rating Scale at 6 months. The NRS is a scale of 0 (no pain) to 10 (worst pain imaginable)

  3. Patients Global Impression of Change [ Time Frame: 3 Months ]
    Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)

  4. Patients Global Impression of Change [ Time Frame: 6 Months ]
    Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)

  5. Opioid analgesic use at 3 months [ Time Frame: 3 months ]
    Opioid analgesic daily use by self reporting .

  6. Opioid analgesic use at 6 months [ Time Frame: 6 months ]
    Opioid analgesic daily use by self reporting.

  7. Non-opioid analgesic use at 3 months [ Time Frame: 3 Months ]
    Non opioid analgesic daily use by self reporting.

  8. Non-opioid analgesic use at 6 months [ Time Frame: 6 Months ]
    Non opioid analgesic daily use by self reporting.

  9. PROMIS Pain Intensity Short Form 3a [ Time Frame: Baseline ]
    3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)

  10. PROMIS Pain Intensity Short Form 3a [ Time Frame: 3 Months ]
    3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)

  11. PROMIS Pain Intensity Short Form 3a [ Time Frame: 6 Months ]
    3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)

  12. PROMIS Sleep Disturbance Short Form 4a [ Time Frame: Baseline ]
    4 question sleep survey. First section is quality of sleep rated on a 5 response (very poor)- (very good) scale.Section rating quality of sleep based on 5 response choices (not at all) to (very much)

  13. PROMIS Sleep Disturbance Short Form 4a [ Time Frame: 3 Months ]
    4 question sleep survey. First section is quality of sleep rated on a 5 response (very poor)- (very good) scale.Section rating quality of sleep based on 5 response choices (not at all) to (very much)

  14. PROMIS Sleep Disturbance Short Form 4a [ Time Frame: 6 Months ]
    4 question sleep survey. First section is quality of sleep rated on a 5 response (very poor)- (very good) scale.Section rating quality of sleep based on 5 response choices (not at all) to (very much)

  15. PROMIS Pain Interference Short Form 6b [ Time Frame: Baseline ]
    6 question pain survey. First section is interference of pain rated on a 5 response (not at all)- (very much) scale. Section is one socialization question with 5 response choices (never)- (always)

  16. PROMIS Pain Interference Short Form 6b [ Time Frame: 3 Months ]
    6 question pain survey. First section is interference of pain rated on a 5 response (not at all)- (very much) scale. Section is one socialization question with 5 response choices (never)- (always)

  17. PROMIS Pain Interference Short Form 6b [ Time Frame: 6 Months ]
    6 question pain survey. First section is interference of pain rated on a 5 response (not at all)- (very much) scale. Section is one socialization question with 5 response choices (never)- (always)

  18. Oxford Knee Score [ Time Frame: Baseline ]
    12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.

  19. Oxford Knee Score [ Time Frame: 6 Months ]
    12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.

  20. Hospital Anxiety and Depression Scale [ Time Frame: Baseline ]
    Hospital Anxiety and Depression Scale (HADS) is a 14 question survey (7 anxiety and 7 depression) questions answered on a 0 (low) - 3 (high) scale.Total score of 0-7 is normal, 8-10 is baseline abnormal and a score between 11-21 is abnormal.

  21. Hospital Anxiety and Depression Scale [ Time Frame: 3 Month ]
    Hospital Anxiety and Depression Scale (HADS) is a 14 question survey (7 anxiety and 7 depression) questions answered on a 0 (low) - 3 (high) scale.Total score of 0-7 is normal, 8-10 is baseline abnormal and a score between 11-21 is abnormal.

  22. Hospital Anxiety and Depression Scale [ Time Frame: 6 Month ]
    Hospital Anxiety and Depression Scale (HADS) is a 14 question survey (7 anxiety and 7 depression) questions answered on a 0 (low) - 3 (high) scale. Total score of 0-7 is normal, 8-10 is baseline abnormal and a score between 11-21 is abnormal.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 40-95 years
  • Patients with knee pain, on average > 4 (NRS) persisting more than 6 months after TKA
  • Willingness to undergo image guided diagnostic nerve block and the study intervention

Exclusion Criteria:

  • Pain score (NRS) < 4 at time of study enrollment
  • Conditions that preclude the diagnostic block or the study intervention (e.g., irreversible coagulopathy or bleeding disorder, allergic reaction/contraindication to local anesthetic, contrast dye, steroids, and/or phenol, pregnancy, severe or uncontrolled medical illness).
  • Evidence of indolent infection of the knee prosthesis (elevated C-reactive protein assessed when clinically indicated)
  • Inability to write, speak, or read in English
  • Pregnancy
Contacts and Locations

Contacts
Layout table for location contacts
Contact: David Walega, MD 312-695-2500 d-walega@northwestern.edu

Locations
Layout table for location information
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: David Walega, MD    312-695-2500    d-walega@northwestern.edu   
Principal Investigator: David Walega, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Layout table for investigator information
Principal Investigator: David Walega, MD Northwestern University
Tracking Information
First Submitted Date  ICMJE May 28, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date March 3, 2021
Actual Study Start Date  ICMJE May 24, 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019) 		Oxford Knee Score [ Time Frame: 3 months ]
Oxford Knee Score is a tool which measures 6 post operative items (pain,flexion contracture, extension lag, total range of flexion, alignment of varus and valgus,stability (antero-posterior and mediolateral). The scoring is: below 60 is poor, scoring 60-69 fair, scoring 70-79 good, 80-100 excellent.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Numeric Rating Scale Score [ Time Frame: 3months ]
    The proportion of subjects who have > 50% reduction in pain based on the Numeric Rating Scale at 3 months. The NRS is a scale of 0 (no pain) to 10 (worst pain imaginable)
  • Numeric Rating Scale Score [ Time Frame: 6 months ]
    The proportion of subjects who have > 50% reduction in pain based on the Numeric Rating Scale at 6 months. The NRS is a scale of 0 (no pain) to 10 (worst pain imaginable)
  • Patients Global Impression of Change [ Time Frame: 3 Months ]
    Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)
  • Patients Global Impression of Change [ Time Frame: 6 Months ]
    Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)
  • Opioid analgesic use at 3 months [ Time Frame: 3 months ]
    Opioid analgesic daily use by self reporting .
  • Opioid analgesic use at 6 months [ Time Frame: 6 months ]
    Opioid analgesic daily use by self reporting.
  • Non-opioid analgesic use at 3 months [ Time Frame: 3 Months ]
    Non opioid analgesic daily use by self reporting.
  • Non-opioid analgesic use at 6 months [ Time Frame: 6 Months ]
    Non opioid analgesic daily use by self reporting.
  • PROMIS Pain Intensity Short Form 3a [ Time Frame: Baseline ]
    3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)
  • PROMIS Pain Intensity Short Form 3a [ Time Frame: 3 Months ]
    3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)
  • PROMIS Pain Intensity Short Form 3a [ Time Frame: 6 Months ]
    3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)
  • PROMIS Sleep Disturbance Short Form 4a [ Time Frame: Baseline ]
    4 question sleep survey. First section is quality of sleep rated on a 5 response (very poor)- (very good) scale.Section rating quality of sleep based on 5 response choices (not at all) to (very much)
  • PROMIS Sleep Disturbance Short Form 4a [ Time Frame: 3 Months ]
    4 question sleep survey. First section is quality of sleep rated on a 5 response (very poor)- (very good) scale.Section rating quality of sleep based on 5 response choices (not at all) to (very much)
  • PROMIS Sleep Disturbance Short Form 4a [ Time Frame: 6 Months ]
    4 question sleep survey. First section is quality of sleep rated on a 5 response (very poor)- (very good) scale.Section rating quality of sleep based on 5 response choices (not at all) to (very much)
  • PROMIS Pain Interference Short Form 6b [ Time Frame: Baseline ]
    6 question pain survey. First section is interference of pain rated on a 5 response (not at all)- (very much) scale. Section is one socialization question with 5 response choices (never)- (always)
  • PROMIS Pain Interference Short Form 6b [ Time Frame: 3 Months ]
    6 question pain survey. First section is interference of pain rated on a 5 response (not at all)- (very much) scale. Section is one socialization question with 5 response choices (never)- (always)
  • PROMIS Pain Interference Short Form 6b [ Time Frame: 6 Months ]
    6 question pain survey. First section is interference of pain rated on a 5 response (not at all)- (very much) scale. Section is one socialization question with 5 response choices (never)- (always)
  • Oxford Knee Score [ Time Frame: Baseline ]
    12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.
  • Oxford Knee Score [ Time Frame: 6 Months ]
    12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.
  • Hospital Anxiety and Depression Scale [ Time Frame: Baseline ]
    Hospital Anxiety and Depression Scale (HADS) is a 14 question survey (7 anxiety and 7 depression) questions answered on a 0 (low) - 3 (high) scale.Total score of 0-7 is normal, 8-10 is baseline abnormal and a score between 11-21 is abnormal.
  • Hospital Anxiety and Depression Scale [ Time Frame: 3 Month ]
    Hospital Anxiety and Depression Scale (HADS) is a 14 question survey (7 anxiety and 7 depression) questions answered on a 0 (low) - 3 (high) scale.Total score of 0-7 is normal, 8-10 is baseline abnormal and a score between 11-21 is abnormal.
  • Hospital Anxiety and Depression Scale [ Time Frame: 6 Month ]
    Hospital Anxiety and Depression Scale (HADS) is a 14 question survey (7 anxiety and 7 depression) questions answered on a 0 (low) - 3 (high) scale. Total score of 0-7 is normal, 8-10 is baseline abnormal and a score between 11-21 is abnormal.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain
Official Title  ICMJE Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain Following Total Knee Arthroplasty: a Pilot Prospective, Randomized, Crossover Trial
Brief Summary

Chronic knee pain from osteoarthritis (OA) is commonly treated with total knee arthroplasty (TKA) when conservative therapies fail to provide pain relief. More than 600,000 TKAs are performed in the U.S. annually, a number that continues to increase. A logistic-regression model suggests that the incidence rate of TKA will increase by 143% in the United States by 2050 compared to 2012. Although TKA is successful in reducing knee pain and joint stiffness in most cases, it can be associated with a 7-35% incidence of persistent refractory post-surgical knee pain.

Aim:

To determine whether chemical neurolysis of the genicular nerves with 6% aqueous phenol is non-inferior in reducing knee pain as compared to corticosteroid injection of the genicular nerves, in patients with refractory chronic knee pain for more than 6 months after total knee replacement.

Hypothesis:

Chemical neurolysis of genicular nerves with phenol will provide equal or superior pain relief than corticosteroid genicular nerve injections at 3 months, as measured by the Oxford Knee Score.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
A Pilot Prospective, Randomized, Crossover Trial. (Block randomization scheme with 2:1 allocation (phenol neurolysis : perineural steroid injection) The crossover will occur in subjects who received the steroid injection who did not achieve adequate pain relief at 3 months.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain, Chronic
Intervention  ICMJE
  • Drug: Phenol Injection
    6% aqueous phenol 2.5 mL will be mixed with 0.5 mL iopamidol 300 and will be injected at each target site with live, pulsed fluoroscopy (5-8 seconds at each location) to observe the contrast dye-tagged phenol covering the lateral margin of the femur or tibia respectively on AP and lateral views. The needles will then be removed and band-aids placed.
    Other Name: Phenol
  • Drug: Methylprednisolone Injection
    Methylprednisolone acetate 10 mg with 2 mL preservative saline and 0.5 mL iopamidol 300 will be injected at each of the 3 target sites with live, pulsed fluoroscopy (5-8 seconds at each location) to observe the contrast dye-tagged steroid mixture covering the lateral margin of the femur or tibia respectively on AP and lateral views; the needles will be removed and band-aids placed.
    Other Name: Methylprednisolone acetate
Study Arms  ICMJE
  • Experimental: Treatment Group: Phenol injection
    6% aqueous phenol 2.5 mL will be mixed with 0.5 mL iopamidol 300 and will be injected at each target sites
    Intervention: Drug: Phenol Injection
  • Control Group: Methylprednisolone injection
    Methylprednisolone acetate 10 mg with 2 mL preservative free saline and 0.5 mL iopamidol 300 will be injected at each of the target site
    Intervention: Drug: Methylprednisolone Injection
Publications *
  • Nguyen US, Zhang Y, Zhu Y, Niu J, Zhang B, Felson DT. Increasing prevalence of knee pain and symptomatic knee osteoarthritis: survey and cohort data. Ann Intern Med. 2011 Dec 6;155(11):725-32. doi: 10.7326/0003-4819-155-11-201112060-00004.
  • Buvanendran A, Fiala J, Patel KA, Golden AD, Moric M, Kroin JS. The Incidence and Severity of Postoperative Pain following Inpatient Surgery. Pain Med. 2015 Dec;16(12):2277-83. doi: 10.1111/pme.12751. Epub 2015 Apr 27.
  • Lewis GN, Rice DA, McNair PJ, Kluger M. Predictors of persistent pain after total knee arthroplasty: a systematic review and meta-analysis. Br J Anaesth. 2015 Apr;114(4):551-61. doi: 10.1093/bja/aeu441. Epub 2014 Dec 26. Review.
  • Drosos GI, Triantafilidou T, Ververidis A, Agelopoulou C, Vogiatzaki T, Kazakos K. Persistent post-surgical pain and neuropathic pain after total knee replacement. World J Orthop. 2015 Aug 18;6(7):528-36. doi: 10.5312/wjo.v6.i7.528. eCollection 2015 Aug 18.
  • Puolakka PA, Rorarius MG, Roviola M, Puolakka TJ, Nordhausen K, Lindgren L. Persistent pain following knee arthroplasty. Eur J Anaesthesiol. 2010 May;27(5):455-60. doi: 10.1097/EJA.0b013e328335b31c.
  • Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10. Review.
  • Inacio MCS, Paxton EW, Graves SE, Namba RS, Nemes S. Projected increase in total knee arthroplasty in the United States - an alternative projection model. Osteoarthritis Cartilage. 2017 Nov;25(11):1797-1803. doi: 10.1016/j.joca.2017.07.022. Epub 2017 Aug 8.
  • Sylvester LN, Goree JH. Genicular Radiofrequency Ablation for Treatment of Post Total Knee Arthroplasty Posterior Thigh Pain: A Case Report. A A Case Rep. 2017 Nov 15;9(10):292-293. doi: 10.1213/XAA.0000000000000596.
  • Qudsi-Sinclair S, Borrás-Rubio E, Abellan-Guillén JF, Padilla Del Rey ML, Ruiz-Merino G. A Comparison of Genicular Nerve Treatment Using Either Radiofrequency or Analgesic Block with Corticosteroid for Pain after a Total Knee Arthroplasty: A Double-Blind, Randomized Clinical Study. Pain Pract. 2017 Jun;17(5):578-588. doi: 10.1111/papr.12481. Epub 2016 Sep 19.
  • Protzman NM, Gyi J, Malhotra AD, Kooch JE. Examining the feasibility of radiofrequency treatment for chronic knee pain after total knee arthroplasty. PM R. 2014 Apr;6(4):373-6. doi: 10.1016/j.pmrj.2013.10.003. Epub 2013 Dec 27.
  • Walega DR, McCormick ZL. Chemical Neurolysis of the Genicular Nerves for Chronic Knee Pain: Reviving an Old Dog and an Old Trick. Pain Med. 2018 Sep 1;19(9):1882-1884. doi: 10.1093/pm/pny023.
  • Koyyalagunta D, Engle MP, Yu J, Feng L, Novy DM. The Effectiveness of Alcohol Versus Phenol Based Splanchnic Nerve Neurolysis for the Treatment of Intra-Abdominal Cancer Pain. Pain Physician. 2016 May;19(4):281-92.
  • Wang PJ, Shang MY, Qian Z, Shao CW, Wang JH, Zhao XH. CT-guided percutaneous neurolytic celiac plexus block technique. Abdom Imaging. 2006 Nov-Dec;31(6):710-8. Review.
  • Kirazli Y, On AY, Kismali B, Aksit R. Comparison of phenol block and botulinus toxin type A in the treatment of spastic foot after stroke: a randomized, double-blind trial. Am J Phys Med Rehabil. 1998 Nov-Dec;77(6):510-5.
  • Ahmed A, Arora D, Kochhar AK. Ultrasound-guided alcohol neurolysis of lateral femoral cutaneous nerve for intractable meralgia paresthetica: a case series. Br J Pain. 2016 Nov;10(4):232-237. Epub 2016 Sep 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages 40-95 years
  • Patients with knee pain, on average > 4 (NRS) persisting more than 6 months after TKA
  • Willingness to undergo image guided diagnostic nerve block and the study intervention

Exclusion Criteria:

  • Pain score (NRS) < 4 at time of study enrollment
  • Conditions that preclude the diagnostic block or the study intervention (e.g., irreversible coagulopathy or bleeding disorder, allergic reaction/contraindication to local anesthetic, contrast dye, steroids, and/or phenol, pregnancy, severe or uncontrolled medical illness).
  • Evidence of indolent infection of the knee prosthesis (elevated C-reactive protein assessed when clinically indicated)
  • Inability to write, speak, or read in English
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Walega, MD 312-695-2500 d-walega@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03973177
Other Study ID Numbers  ICMJE STU00209591
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Walega, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Walega, MD Northwestern University
PRS Account Northwestern University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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