Neuromodulation for Patients With Parkinson's Disease

Felipe Fregni, MD, PhD, MPH

Status: Not yet enrolling

Conditions: Adults With Parkinson's Disease

Treatments: Device: tDCS combined with TUS

Study type: Interventional

Funder types: Other

Identifiers

NCT07767006

2026P001926

Details and patient eligibility

About

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).

Enrollment: 116 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of idiopathic PD with self-reported balance impairment or postural instability.
2. Age 40 to 85 years.
3. Have at least moderate motor impairment (defined by minimum UPDRS Part III (motor) score of 20 while ON medication state).
4. 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.

Exclusion criteria

1. 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.
2. 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.
3. Cognitive or communication impairment preventing comprehension of instructions or valid consent (e.g., dementia, severe cognitive impairment, aphasia, intellectual disability, or language barrier).
4. Severe musculoskeletal conditions (e.g., advanced arthritis, joint deformities) that substantially interfere with independent movement or balance.
5. Clinically unstable medical conditions (e.g., uncontrolled diabetes, decompensated cardiac disease, heart failure, decompensated pulmonary disease, COPD).
6. 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.
7. Contraindications to noninvasive brain stimulation or transcranial ultrasound according to the latest published safety tDCS and TUS guidelines.
8. Active, uncontrolled psychiatric illness that may interfere with safe participation or study compliance, including schizophrenia, bipolar disorder, uncontrolled psychosis, or suicidality.
9. 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.
10. History of neurosurgical interventions including deep brain stimulation, brain ablation, or documented malignant intracranial mass lesions.
11. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

116 participants in 4 patient groups

Standard Protocol

Experimental group

Description:

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

Treatment:

Device: tDCS combined with TUS

Distributed Protocol

Active Comparator group

Description:

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

Treatment:

Device: tDCS combined with TUS

Short Protocol

Active Comparator group

Description:

tDCS and TUS for 5 sessions over 1 week

Treatment:

Device: tDCS combined with TUS

Sham

Sham Comparator group

Description:

Sham stimulation for 10 sessions; 5/week for 2 weeks

Treatment:

Device: tDCS combined with TUS