Brain Stimulation + Physical Therapy for Parkinson's Disease

N/A

Recruiting

Led By Felipe Fregni, MD, PhD

Research Sponsored by Spaulding Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age from 40 to 90 years old

Be older than 18 years old

Must not have

History of deep brain stimulation or brain ablation surgeries, malignant mass brain lesions

Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups

Summary

This trial is testing whether a combination of transcranial direct current stimulation (tDCS) and transcranial ultrasound (TUS) can help improve postural instability in Parkinson's disease patients receiving physical therapy.

Who is the study for?

This trial is for people aged 40-90 with Parkinson's Disease who have balance issues or postural instability and are on stable PD medications. Excluded are those with other balance-affecting conditions, brain surgeries, metal in the head, severe medical problems, pregnancy, recent PT programs, non-PD parkinsonism syndromes, certain psychiatric or substance abuse histories.

What is being tested?

The study tests if brain stimulation (tDCS) plus ultrasound (TUS), along with physical therapy (PT), can improve stability in Parkinson's patients. It's a double-blind study where participants randomly get either real treatment or sham (fake) versions for two weeks followed by biweekly sessions.

What are the potential side effects?

Potential side effects of tDCS and TUS may include discomfort at the stimulation site, headache, dizziness or nausea during application. However specific risks related to these treatments will be monitored closely throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had brain surgery or have malignant brain tumors.

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My medical conditions, like diabetes or heart issues, are under control.

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I have a condition like epilepsy or another that makes seizures more likely.

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I am confined to a bed or wheelchair.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups for reporting.