Adults With Parkinson's DiseaseNCT07767006
Neuromodulation for Patients With Parkinson's Disease
A study testing tDCS combined with TUS in people with Adults With Parkinson's Disease, run by Felipe Fregni, MD, PhD, MPH at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Adults With Parkinson's Disease
- What is being tested?
- tDCS combined with TUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD with self-reported balance impairment or postural instability.
- Age 40 to 85 years.
- Have at least moderate motor impairment (defined by minimum UPDRS Part III (motor) score of 20 while ON medication state).
- On stable Parkinson's disease medications for at least 30 days prior to enrollment, based on self-report. Dose changes of up to 20% in dopaminergic medications during this period are considered stable.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Spaulding Rehabilitation Hospital for Continuing Care
Cambridge, Massachusetts, 02138
About this study
Official title: Neuromodulation for the Treatment of Postural Instability in Patients With Parkinson's Disease
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. Participants will be randomly assigned to one of four groups: Standard (10 sessions delivered five times per week for two weeks), Distributed (six sessions delivered three times per week for two weeks), Short (five sessions delivered over one week), or Sham (10 sham sessions delivered five times per week for two weeks).
- Conditions
- Adults With Parkinson's Disease
- Being tested
- tDCS combined with TUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Protocol | Experimental | tDCS combined with TUS for 10 sessions; 5/week for 2 weeks Receives: Device: tDCS combined with TUS |
| Distributed Protocol | Active comparator | tDCS and TUS for 6 sessions; 3/week for 2 weeks Receives: Device: tDCS combined with TUS |
| Short Protocol | Active comparator | tDCS and TUS for 5 sessions over 1 week Receives: Device: tDCS combined with TUS |
| Sham | Sham comparator | Sham stimulation for 10 sessions; 5/week for 2 weeks Receives: Device: tDCS combined with TUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline-adjusted change in UPDRS Part III from end-of-stimulation through 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults With Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Felipe Fregni, MD, PhD, MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767006
- Sponsor's protocol ID
- 2026P001926
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation for the Treatment of Postural Instability in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07767006
- Acronym / sponsor ID
- 2026P001926
- Conditions
- Adults With Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Felipe Fregni, MD, PhD, MPHUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Participants will be randomly assigned to one of four groups: Standard (10 sessions delivered five times per week for two weeks), Distributed (six sessions delivered three times per week for two weeks), Short (five sessions delivered over one week), or Sham (10 sham sessions delivered five times per week for two weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Protocol | Experimental | Device: tDCS combined with TUStDCS combined with TUS for 10 sessions; 5/week for 2 weeks |
| Distributed Protocol | Active comparator | Device: tDCS combined with TUStDCS and TUS for 6 sessions; 3/week for 2 weeks |
| Short Protocol | Active comparator | Device: tDCS combined with TUStDCS and TUS for 5 sessions over 1 week |
| Sham | Sham comparator | Device: tDCS combined with TUSSham stimulation for 10 sessions; 5/week for 2 weeks |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of idiopathic PD with self-reported balance impairment or postural instability.
- Age 40 to 85 years.
- Have at least moderate motor impairment (defined by minimum UPDRS Part III (motor) score of 20 while ON medication state).
- On stable Parkinson's disease medications for at least 30 days prior to enrollment, based on self-report. Dose changes of up to 20% in dopaminergic medications during this period are considered stable.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS combined with TUSThis study will compare different treatment schedules of combined transcranial direct current stimulation (tDCS) and transcranial ultrasound stimulation (TUS) in participants with Parkinson's disease. | Device | Distributed Protocol, Sham, Short Protocol, Standard Protocol |
Primary outcome
Improvement in Unified Parkinson's Disease Rating Scale (UPDRS) Part III
Time frame: Baseline-adjusted change in UPDRS Part III from end-of-stimulation through 12 weeks.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS combined with TUS in people with Adults With Parkinson's Disease, run by Felipe Fregni, MD, PhD, MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felipe Fregni (6179526154, fregni.felipe@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Unified Parkinson's Disease Rating Scale (UPDRS) Part III (time frame: Baseline-adjusted change in UPDRS Part III from end-of-stimulation through 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.