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出境医 / 临床实验 / Improving Hand Recovery With Neuromodulation in Tetraplegia (IGNITE)

Improving Hand Recovery With Neuromodulation in Tetraplegia (IGNITE)

Study Description
Brief Summary:
This study will examine a form of non-invasive brain stimulation applied with intensive therapy of the arm and hand. The goal of the study is to determine if arm and hand function can be improved in people with incomplete cervical spinal cord injury (neck spinal cord injury, tetraplegia). Participants will be assigned to receive either active or inactive non-invasive brain stimulation.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Tetraplegia, Unspecified, Incomplete, Chronic Device: transcranial direct current stimulation Behavioral: Intensive upper extremity motor training Not Applicable

Detailed Description:
This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of two groups by chance. One group will receive tDCS at a level expected to increase the brain's ability to change, while the other group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their more impaired arm and hand, focusing on exercises that are meaningful to him/her.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Hand Recovery With Neuromodulation in Tetraplegia
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Active tDCS
Subjects will receive 20 minutes of active transcranial direct current stimulation at 2.5mA, followed by 2 hours of intensive motor therapy of the more affected upper extremity.
Device: transcranial direct current stimulation
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.

Behavioral: Intensive upper extremity motor training
This training is administered one-on-one with an occupational therapist. Activities will be focused on skills the participant wants to regain.

Sham Comparator: Sham tDCS
Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the more affected upper extremity.
Device: transcranial direct current stimulation
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.

Behavioral: Intensive upper extremity motor training
This training is administered one-on-one with an occupational therapist. Activities will be focused on skills the participant wants to regain.

Outcome Measures
Primary Outcome Measures :
  1. Change in Spinal Cord Independence Measure [ Time Frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up ]
    This evaluates self-care, respiration and sphincter management, and mobility.


Secondary Outcome Measures :
  1. Change in Medical Research Council Scale Upper Extremity Manual Muscle Test [ Time Frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up ]
    This evaluates the strength of various muscles in the upper extremity. Each muscle that is tested can be scored from a minimum of 0, indicating no strength, up to a maximum of 5, indicating normal strength. Scores are assigned to each side by summing the scores from each of the 41 individual muscles, with a minimum possible total score of 0 and a maximum possible total score of 205. Higher values indicate greater strength.

  2. Change in Canadian Occupational Performance Measure [ Time Frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up ]
    The participant selects 5 tasks they would like to be able to perform, and score their performance as well as satisfaction with their performance of the tasks.

  3. Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension [ Time Frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up ]
    This measures strength, sensibility, and prehension to obtain information about motor and sensory function.

  4. Change in Van Lieshout Test [ Time Frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up ]
    This test evaluates upper extremity motor performance in cervical spinal cord injury.

  5. Change in cortical motor map volume [ Time Frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up ]
    This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm or hand.

  6. Semi-structured interview about study [ Time Frame: Baseline ]
    Participants will be asked about motivations and goals for the study.

  7. Semi-structured interview about study [ Time Frame: Immediately post-intervention, 4-month follow-up ]
    Participants will be asked about their experience in the study, whether they experienced any changes in function during the study, and whether they have recommendations for change.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. traumatic, incomplete cervical SCI sustained at neurological level C4-C7 and classified as B, C or D by the American Spinal Injury Association Impairment Scale (AIS);
  2. sustained injury at least 1 year prior to enrollment (i.e., chronic); and
  3. Men and women between the ages of 18-65.

Exclusion Criteria:

  1. history of head injury, seizures, severe alcohol or drug abuse, or psychiatric illness;
  2. cognitive deficits severe enough to preclude informed consent;
  3. positive pregnancy test or being of childbearing age and not using appropriate contraception;
  4. presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain;
  5. decubitus ulcers that might interfere with intervention;
  6. cardiac or neural pacemakers;
  7. fixed UE contractures;
  8. untreated depression;
  9. concurrent participation in occupational therapy;
  10. within 3 months of recruitment, an addition or change in the dosage of drugs known to exert detrimental effects on motor recovery.
Contacts and Locations

Contacts
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Contact: Elizabeth Powell, MS (859) 323-6889 elizabeth.salmon@uky.edu

Locations
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United States, Kentucky
University of Kentucky at Cardinal Hill Rehabilitation Hospital Recruiting
Lexington, Kentucky, United States, 40504
Contact: Elizabeth Powell, MS    859-323-6889    elizabeth.salmon@uky.edu   
Sponsors and Collaborators
Sara Shahid Salles
Wings for Life
Investigators
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Principal Investigator: Sara Salles, MD University of Kentucky
Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date March 3, 2021
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
Change in Spinal Cord Independence Measure [ Time Frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up ]
This evaluates self-care, respiration and sphincter management, and mobility.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Change in Medical Research Council Scale Upper Extremity Manual Muscle Test [ Time Frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up ]
    This evaluates the strength of various muscles in the upper extremity. Each muscle that is tested can be scored from a minimum of 0, indicating no strength, up to a maximum of 5, indicating normal strength. Scores are assigned to each side by summing the scores from each of the 41 individual muscles, with a minimum possible total score of 0 and a maximum possible total score of 205. Higher values indicate greater strength.
  • Change in Canadian Occupational Performance Measure [ Time Frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up ]
    The participant selects 5 tasks they would like to be able to perform, and score their performance as well as satisfaction with their performance of the tasks.
  • Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension [ Time Frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up ]
    This measures strength, sensibility, and prehension to obtain information about motor and sensory function.
  • Change in Van Lieshout Test [ Time Frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up ]
    This test evaluates upper extremity motor performance in cervical spinal cord injury.
  • Change in cortical motor map volume [ Time Frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up ]
    This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm or hand.
  • Semi-structured interview about study [ Time Frame: Baseline ]
    Participants will be asked about motivations and goals for the study.
  • Semi-structured interview about study [ Time Frame: Immediately post-intervention, 4-month follow-up ]
    Participants will be asked about their experience in the study, whether they experienced any changes in function during the study, and whether they have recommendations for change.
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 Improving Hand Recovery With Neuromodulation in Tetraplegia
Official Title  ICMJE Improving Hand Recovery With Neuromodulation in Tetraplegia
Brief Summary This study will examine a form of non-invasive brain stimulation applied with intensive therapy of the arm and hand. The goal of the study is to determine if arm and hand function can be improved in people with incomplete cervical spinal cord injury (neck spinal cord injury, tetraplegia). Participants will be assigned to receive either active or inactive non-invasive brain stimulation.
Detailed Description This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of two groups by chance. One group will receive tDCS at a level expected to increase the brain's ability to change, while the other group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their more impaired arm and hand, focusing on exercises that are meaningful to him/her.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injuries
  • Tetraplegia, Unspecified, Incomplete, Chronic
Intervention  ICMJE
  • Device: transcranial direct current stimulation
    This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
  • Behavioral: Intensive upper extremity motor training
    This training is administered one-on-one with an occupational therapist. Activities will be focused on skills the participant wants to regain.
Study Arms  ICMJE
  • Experimental: Active tDCS
    Subjects will receive 20 minutes of active transcranial direct current stimulation at 2.5mA, followed by 2 hours of intensive motor therapy of the more affected upper extremity.
    Interventions:
    • Device: transcranial direct current stimulation
    • Behavioral: Intensive upper extremity motor training
  • Sham Comparator: Sham tDCS
    Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the more affected upper extremity.
    Interventions:
    • Device: transcranial direct current stimulation
    • Behavioral: Intensive upper extremity motor training
Publications * Not Provided

*   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: May 15, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. traumatic, incomplete cervical SCI sustained at neurological level C4-C7 and classified as B, C or D by the American Spinal Injury Association Impairment Scale (AIS);
  2. sustained injury at least 1 year prior to enrollment (i.e., chronic); and
  3. Men and women between the ages of 18-65.

Exclusion Criteria:

  1. history of head injury, seizures, severe alcohol or drug abuse, or psychiatric illness;
  2. cognitive deficits severe enough to preclude informed consent;
  3. positive pregnancy test or being of childbearing age and not using appropriate contraception;
  4. presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain;
  5. decubitus ulcers that might interfere with intervention;
  6. cardiac or neural pacemakers;
  7. fixed UE contractures;
  8. untreated depression;
  9. concurrent participation in occupational therapy;
  10. within 3 months of recruitment, an addition or change in the dosage of drugs known to exert detrimental effects on motor recovery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth Powell, MS (859) 323-6889 elizabeth.salmon@uky.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954496
Other Study ID Numbers  ICMJE 201810171642
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
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 Sara Shahid Salles, University of Kentucky
Study Sponsor  ICMJE Sara Shahid Salles
Collaborators  ICMJE Wings for Life
Investigators  ICMJE
Principal Investigator: Sara Salles, MD University of Kentucky
PRS Account University of Kentucky
Verification Date February 2021

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