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

NCT03981055 | Active Not Recruiting Results FDA Device

• 2 other identifiers: 2018P002733R44NS110237
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Improvement in Unified Parkinson's Disease Rating Scale (UPDRS) Part III

  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).

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

Study Arms (2)

Active tDCS and Active TUS

EXPERIMENTAL

Active tDCS and Active TUS for 20 min

Device: Active Comparator: Active tDCS and Active TUS; Other: Physical Therapy

Sham TDCS and Sham TUS

SHAM COMPARATOR

Sham TDCS and Sham TUS for 20 min

Device: Sham Comparator: Sham TDCS and Sham TUS; Other: Physical Therapy

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.

Active tDCS and Active TUS

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)

Active tDCS and Active TUS; Sham TDCS and Sham TUS

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.

Sham TDCS and Sham TUS

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of "probable" or "possible" PD, as defined by the current clinical criteria (Gelb D, Oliver E, Gilman S. Diagnostic Criteria for Parkinson's Disease. Arch Neurol.1999;56:33-39) as confirmed by co-investigator neurologist, or confirmation via medical records or a letter from patient physician;
• Complaints about balance impairment or postural instability due to PD (self-report);
• Age from 40 to 90 years old;
• Taking stable medications for PD for at least 30 days.

You may not qualify if:

• Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes;
• History of deep brain stimulation or brain ablation surgeries, malignant mass brain lesions;
• History of schizophrenia, bipolar illness; history of alcohol/drug abuse within the past 6 months;
• Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;
• Contraindications to transcranial brain stimulation or TUS, i.e. metal in the head, implanted brain medical devices, etc.;
• Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease);
• Pregnancy.
• Epilepsy or disorders that significantly increase likelihood of seizures including: severe traumatic brain injury, congenital birth defects leading to seizures, brain tumor, metabolic disorders associated with seizures, intracranial or subarachnoid hemorrhage, and nonlacunar strokes.
• Recent (\<= 2 months) or planned enrollment in an additional physician prescribed physical therapy program during their time in the trial.
• Presence of another disorder that might have a significant impact on balance (as assessed by a co-investigator neurologist).
• Bed or wheelchair-bound

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Highland Instruments, Inc.: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Results Point of Contact

• Title: Felipe Fregni
• Organization: Spaulding Rehabilitation Hospital

fregni.felipe@mgh.harvard.edu

6179526158

Study Officials

• Felipe Fregni, MD, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital & Massachusetts General Hospital, Harvard Medical School

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: June 10, 2019
• Study Start: January 23, 2020
• Primary Completion: April 30, 2024
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 3, 2026
• Results First Posted: November 10, 2025

Record last verified: 2026-02

Locations

US (1)