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Neuromodulation for Patients With Parkinson's Disease

Neuromodulation for the Treatment of Postural Instability in Patients With Parkinson's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 weeks, 1 week
  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares schedules for two types of brain stimulation used together: tDCS, which uses electrical current, and TUS, which uses ultrasound waves. It is for adults ages 40 to 85 with Parkinson's disease and balance problems. People are assigned by chance to one of three treatment schedules or a sham group that does not get active stimulation.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have idiopathic Parkinson's disease, meaning its cause is unknown, and report trouble with balance or staying steady.
  • Be 40 to 85 years old.
  • Have at least moderate movement problems, with a score of 20 or higher on the UPDRS movement test while Parkinson's medicine is working.
  • Have taken stable Parkinson's medicines for at least 30 days. Changes of up to 20% in medicines that affect dopamine are allowed.

Who can't join

  • Have early or very advanced Parkinson's disease: a modified Hoehn and Yahr stage of 2 or lower, or above 4.
  • Have active epilepsy or a condition that greatly raises seizure risk. Also excluded: taking trihexyphenidyl, benztropine, or methylphenidate. Stable amantadine with normal kidney function, or stable bupropion at 300 mg a day or less, needs approval from the study leader.
  • Have trouble thinking, understanding, or communicating that prevents following instructions or giving informed consent.
  • Have severe muscle, bone, or joint problems that greatly limit movement or balance, or a medical condition that is not stable, such as uncontrolled diabetes or serious heart or lung disease.
  • Started doctor-prescribed balance physical therapy within the past 2 months, or plan to take part during the study. Therapy is allowed if it ended more than 2 months ago, or has been stable for at least 2 months and will continue without major changes.
  • Cannot safely receive tDCS or TUS under current safety guidelines. Also excluded: past brain surgery, including deep brain stimulation or treatment that destroys brain tissue, or a known cancerous mass inside the skull.
  • Have an active, uncontrolled mental illness that could make participation unsafe or make study tasks hard to follow, including thoughts or actions related to suicide.
  • Have had an alcohol or drug use disorder within the past 6 months that caused problems with daily life, relationships, work, or the law, or needed urgent treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

MA