Trial Outcomes & Findings for Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability. (NCT NCT03981055)

Last Updated: 2025-11-10

Results Overview

Motor function was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III - Motor Examination, which measures tremor, rigidity, bradykinesia, postural instability, and gait. Scores range from 0 to 108, where higher scores indicate worse motor impairment (i.e., lower scores represent better motor function).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

40 participants

Primary outcome timeframe

Change from baseline to Day 14 (end of stimulation treatment).

Results posted on

2025-11-10

Participant Flow

Participant milestones

Participant milestones
Measure	Active tDCS and Active TUS Active tDCS and Active TUS for 20 min 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. 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)	Sham TDCS and Sham TUS Sham TDCS and Sham TUS for 20 min 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. 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)
Overall Study STARTED	20	20
Overall Study COMPLETED	19	17
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active tDCS and Active TUS n=20 Participants Active tDCS and Active TUS for 20 min 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. 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)	Sham TDCS and Sham TUS n=20 Participants Sham TDCS and Sham TUS for 20 min 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. 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)	Total n=40 Participants Total of all reporting groups
Age, Continuous	65.35 years STANDARD_DEVIATION 9.33 • n=5 Participants	68.2 years STANDARD_DEVIATION 9.13 • n=20 Participants	66.77 years STANDARD_DEVIATION 9.23 • n=40 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=20 Participants	11 Participants n=40 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	16 Participants n=20 Participants	29 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=20 Participants	2 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	20 Participants n=20 Participants	38 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=20 Participants	40 participants n=40 Participants

PRIMARY outcome

Timeframe: Change from baseline to Day 14 (end of stimulation treatment).

Population: Intention-to-treat population: all randomized participants with Parkinson's disease

Outcome measures

Outcome measures
Measure	Active tDCS and Active TUS n=20 Participants Active tDCS and Active TUS for 20 min 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. 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)	Sham TDCS and Sham TUS n=20 Participants Sham TDCS and Sham TUS for 20 min 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. 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)
Improvement in Unified Parkinson's Disease Rating Scale (UPDRS) Part III	4.42 Scores on a scale (UPDRS). Standard Error 0.42	0.12 Scores on a scale (UPDRS). Standard Error 0.43

Adverse Events

Active tDCS and Active TUS

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Sham TDCS and Sham TUS

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active tDCS and Active TUS n=20 participants at risk Active tDCS and Active TUS for 20 min 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. 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)	Sham TDCS and Sham TUS n=20 participants at risk Sham TDCS and Sham TUS for 20 min 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. 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)
Skin and subcutaneous tissue disorders Tingling	100.0% 20/20 • Number of events 181 • 14 weeks. Adverse effects were collected with a questionnaire for adverse effects.	65.0% 13/20 • Number of events 89 • 14 weeks. Adverse effects were collected with a questionnaire for adverse effects.

Additional Information

Felipe Fregni

Spaulding Rehabilitation Hospital

Phone: 6179526158

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place