Trials Sponsors Conditions Drugs Pricing

Conditions

Adults With Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

Improvement in Unified Parkinson's Disease Rating Scale (UPDRS) Part III
Motor function will be 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).
Baseline-adjusted change in UPDRS Part III from end-of-stimulation through 12 weeks.

Study Arms (4)

Standard Protocol

EXPERIMENTAL

tDCS combined with TUS for 10 sessions; 5/week for 2 weeks

Device: tDCS combined with TUS

Distributed Protocol

ACTIVE COMPARATOR

tDCS and TUS for 6 sessions; 3/week for 2 weeks

Device: tDCS combined with TUS

Short Protocol

ACTIVE COMPARATOR

tDCS and TUS for 5 sessions over 1 week

Device: tDCS combined with TUS

Interventions

tDCS combined with TUSDevice

This study will compare different treatment schedules of combined transcranial direct current stimulation (tDCS) and transcranial ultrasound stimulation (TUS) in participants with Parkinson's disease.

Distributed ProtocolShamShort ProtocolStandard Protocol

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of idiopathic PD with self-reported balance impairment or postural instability.
Age 40 to 85 years.

Sponsors & Collaborators

Felipe Fregni, MD, PhD, MPH
Otherlead

Study Sites (1)

Spaulding Rehabilitation Hospital for Continuing Care

Cambridge, Massachusetts, 02138, United States

Central Study Contacts

Felipe Fregni

CONTACT

6179526154 fregni.felipe@mgh.harvard.edu

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Director, Spaulding Neuromodulation Center

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 17, 2026

Study Start

October 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

You may not qualify if:

Early or advanced stages of disease progression as defined by the modified Hoehn and Yahr stages scores of 2 or less and greater than 4.
Active epilepsy or conditions with significantly increased seizure risk including severe traumatic brain injury, congenital birth defects leading to seizures, brain tumors, metabolic disorders associated with seizures, intracranial or subarachnoid hemorrhage, and nonlacunar strokes.
Cognitive or communication impairment preventing comprehension of instructions or valid consent (e.g., dementia, severe cognitive impairment, aphasia, intellectual disability, or language barrier).
Severe musculoskeletal conditions (e.g., advanced arthritis, joint deformities) that substantially interfere with independent movement or balance.
Clinically unstable medical conditions (e.g., uncontrolled diabetes, decompensated cardiac disease, heart failure, decompensated pulmonary disease, COPD).
Recent (≤2 months) initiation or planned participation in a physician-prescribed physical therapy program targeting balance or postural instability during the study period. Participation is allowed if the program ended more than 2 months before enrollment, or if the participant has been in a stable program for at least 2 months and plans to continue without major changes during the study.
Contraindications to noninvasive brain stimulation or transcranial ultrasound according to the latest published safety tDCS and TUS guidelines.
Active, uncontrolled psychiatric illness that may interfere with safe participation or study compliance, including schizophrenia, bipolar disorder, uncontrolled psychosis, or suicidality.
Current or recent alcohol or substance use disorder within the past 6 months associated with functional, social, occupational, or legal consequences, or requiring acute treatment.
History of neurosurgical interventions including deep brain stimulation, brain ablation, or documented malignant intracranial mass lesions.
Current use of medications that may increase seizure risk, as follows: trihexyphenidyl, benztropine, or methylphenidate. Participants taking amantadine at a stable therapeutic dose with normal renal function or bupropion at a stable therapeutic dose of ≤300 mg/day will be eligible following review by the study principal investigator prior to enrollment.

Neuromodulation for Patients With Parkinson's Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

Standard Protocol

Distributed Protocol

Short Protocol

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Sham

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

Standard Protocol

Distributed Protocol

Short Protocol

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Sham

You may not qualify if:

Source record

Locations