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

NAActive, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 23, 2020

Primary Completion Date

April 30, 2024

Study Completion Date

December 30, 2025

Conditions
Parkinson Disease
Interventions
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."

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. (And during the biweekly sessions for Phase II)

Trial Locations (1)

02129

Spaulding Rehabilitation Network Research Institute, Charlestown

All Listed Sponsors
collaborator

Highland Instruments, Inc.

INDUSTRY

lead

Spaulding Rehabilitation Hospital

OTHER

NCT03981055 - Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability. | Biotech Hunter | Biotech Hunter