CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 40 enrolled
Drug / intervention
Active Comparator: Active tDCS and Active TUS +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03981055
NCT03981055N/AActive
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Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability.

Spaulding Rehabilitation Hospital·interventional·Posted Jun 10, 2019·Updated Mar 3, 2026

In Brief

A clinical study evaluating Active Comparator: Active tDCS and Active TUS, Sham Comparator: Sham TDCS and Sham TUS, and 1 other intervention for Parkinson Disease. Active but no longer recruiting, targeting 40 participants across 1 site.

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesUnited States
CollaboratorsHighland Instruments, Inc., National Institute of Neurological Disorders and Stroke (NINDS)

Timeline

N/AActive
20202021202220232024202520262027
First PostedJun 10, 2019
Enrollment StartJan 23, 2020
Primary CompletionApr 30, 2024
Study CompletionOct 30, 2026
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 7.1 years ago

Interventions

Active Comparator: Active tDCS and Active TUSdevice

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 TUSdevice

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 Therapyother

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)