Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability.

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT03981055
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Active Comparator: Active tDCS and Active TUS — DEVICE
    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.
  • Sham Comparator: Sham TDCS and Sham TUS — DEVICE
    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.
  • Physical Therapy — OTHER
    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. (And during the biweekly sessions for Phase II)

Study Details

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. (Followed by biweekly sessions for 2 more weeks in Phase II)

Key Dates

Start date
Jan 23, 2020
Status verified
Feb 2026
Primary completion
Apr 30, 2024
Completion
Oct 30, 2026

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Active tDCS and Active TUS
    Active tDCS and Active TUS for 20 min
  • Sham Comparator: Sham TDCS and Sham TUS
    Sham TDCS and Sham TUS for 20 min

Primary Outcome Measure

Improvement in Unified Parkinson's Disease Rating Scale (UPDRS) Part III [ Time Frame: Change from baseline to Day 14 (end of stimulation treatment). ]

Locations (1)

FacilityCityStateZIP
Spaulding Rehabilitation Network Research InstituteCharlestownMassachusetts02129

Find similar trials in Charlestown, MA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Spaulding Rehabilitation Network Research Institute· Charlestown, MA

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