Condition or disease | Intervention/treatment | Phase |
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Parkinson Disease | Device: Active Comparator: Active tDCS and Active TUS Device: Sham Comparator: Sham TDCS and Sham TUS Other: Physical Therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability. |
Actual Study Start Date : | January 23, 2020 |
Estimated Primary Completion Date : | May 2021 |
Estimated Study Completion Date : | June 2022 |
Arm | Intervention/treatment |
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Experimental: Active tDCS and Active TUS
Active tDCS and Active TUS for 20 min
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Device: Active Comparator: Active tDCS and Active TUS
Device: Transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes. Other: Physical Therapy All subjects will enroll in a conventional PT balance and gait focused training program, and will receive PT 3x/week over the two weeks of stimulation for 45 minutes following the stimulation sessions when applicable.
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Sham Comparator: Sham TDCS and Sham TUS
Sham TDCS and Sham TUS for 20 min
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Device: Sham Comparator: Sham TDCS and Sham TUS
Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes. Other: Physical Therapy All subjects will enroll in a conventional PT balance and gait focused training program, and will receive PT 3x/week over the two weeks of stimulation for 45 minutes following the stimulation sessions when applicable.
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Ages Eligible for Study: | 40 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Felipe Fregni, MD, PhD | 6179526158 | Fregni.Felipe@mgh.harvard.edu | |
Contact: Meghan Whalen, BS | 6179526158 | MWHALEN7@PARTNERS.ORG |
United States, Massachusetts | |
Spaulding Rehabilitation Network Research Institute | Recruiting |
Charlestown, Massachusetts, United States, 02129 | |
Contact: Felipe Fregni, MD PhD MPH 617-952-6156 ffregni@partners.org | |
Contact: Meghan Whalen, BS 617-952-6158 MWHALEN7@PARTNERS.ORG | |
Principal Investigator: Felipe Fregni, MD PhD MPH |
Principal Investigator: | Felipe Fregni, MD, PhD | Spaulding Rehabilitation Hospital |
Tracking Information | |||||||||
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First Submitted Date ICMJE | January 28, 2019 | ||||||||
First Posted Date ICMJE | June 10, 2019 | ||||||||
Last Update Posted Date | June 4, 2020 | ||||||||
Actual Study Start Date ICMJE | January 23, 2020 | ||||||||
Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Change in postural sway [ Time Frame: 6 weeks ] Postural sway will be assessed through biomechanical assessments using a set of integrated sensors including accelerometers, gyroscopes, force sensors, and motion-capture cameras.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability. | ||||||||
Official Title ICMJE | Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability. | ||||||||
Brief Summary | This trial aims to understand the mechanism and to test whether transcranial direct current stimulation (tDCS) combined with transcranial ultrasound (TUS) (tDCS+TUS) combined with physical therapy (PT) will induce significant therapeutic effects in postural instability in Parkinson's disease (PT) patients. The investigators designed a double-blinded, placebo controlled, randomized study to investigate the effects of 2 weeks of TDCS+TUS on postural instability in PD patients receiving PT. | ||||||||
Detailed Description | Current treatments for Parkinson's Disease (PD), including pharmacological (levodopa) and surgical (DBS) methods, have limited impact on postural instability. Physical therapy (PT) for PD is becoming increasingly used as a means to induce benefits on patient balance. However, limits in efficacy and consistency still exist. In this study, the investigators will test the effects of TDCS+TUS combined with PT on postural instability of PD patients. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Other |
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Condition ICMJE | Parkinson Disease | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
18 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 2022 | ||||||||
Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 90 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03981055 | ||||||||
Other Study ID Numbers ICMJE | 2018P002733 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Felipe Fregni, Spaulding Rehabilitation Hospital | ||||||||
Study Sponsor ICMJE | Spaulding Rehabilitation Hospital | ||||||||
Collaborators ICMJE | Highland Instruments, Inc. | ||||||||
Investigators ICMJE |
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PRS Account | Spaulding Rehabilitation Hospital | ||||||||
Verification Date | June 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |