Brain Stimulation + Physical Therapy for Parkinson's Disease

Overseen By Elly A Pichardo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Must be taking: PD medications

Disqualifiers: Schizophrenia, Bipolar, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining brain stimulation techniques—transcranial direct current stimulation (tDCS) and transcranial ultrasound (TUS)—with physical therapy can improve balance and posture in people with Parkinson's disease. The study is double-blinded and placebo-controlled, meaning some participants receive a placebo to compare results. It suits those with Parkinson's who experience balance issues and have been on stable medication for at least a month. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance the quality of life for Parkinson's patients.

Will I have to stop taking my current medications?

The trial requires that participants have been taking stable medications for Parkinson's disease for at least 30 days, so you will not need to stop your current medications.

What prior data suggests that this brain stimulation technique is safe for Parkinson's disease patients?

Research has shown that both transcranial direct current stimulation (tDCS) and transcranial ultrasound stimulation (TUS) are generally safe. TUS uses sound waves to stimulate the brain and is a non-invasive method with a strong safety record, often used in studies for neurological diseases like Parkinson's.

Similarly, physical therapy (PT) is considered safe for people with Parkinson's disease. Exercise plays a crucial role in managing Parkinson's and has improved symptoms without major safety concerns.

Overall, previous studies suggest that these treatments are well-tolerated when used together. While the specific combination of tDCS and TUS in this trial remains under study, each treatment has demonstrated positive safety results individually. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining brain stimulation techniques with physical therapy for Parkinson's Disease because it offers a fresh approach compared to traditional medications like Levodopa and dopamine agonists. The study uses two innovative brain stimulation methods: transcranial Direct Current Stimulation (tDCS) and transcranial Ultrasound Stimulation (TUS). These techniques aim to improve brain function and motor skills by directly influencing neural activity, which is different from how typical medications work. This combination could potentially enhance physical therapy outcomes and improve quality of life for individuals with Parkinson's.

What evidence suggests that this trial's treatments could be effective for postural instability in Parkinson's disease?

Research suggests that transcranial direct current stimulation (tDCS) might help treat Parkinson's disease. Some studies have found that tDCS can improve walking and balance, common issues for people with Parkinson's. However, not all studies agree, as some have not shown significant improvements. Researchers are also studying transcranial ultrasound stimulation (TUS), but more research is needed to understand its effects. In this trial, participants will receive either active tDCS and active TUS or sham tDCS and sham TUS. Combining tDCS and TUS with physical therapy might lead to better results, as each method offers unique benefits. Overall, this combination is believed to help with balance issues in Parkinson's patients, but more evidence is needed. ^{6 7 8 9 10}

Who Is on the Research Team?

Felipe Fregni, MD, PhD, MPH

Principal Investigator

Spaulding Rehabilitation Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have balance problems or feel unstable standing due to Parkinson's disease.

I am between 40 and 90 years old.

Diagnosis of "probable" or "possible" PD, as defined by the current clinical criteria (Gelb D, Oliver E, Gilman S. Diagnostic Criteria for Parkinson's Disease. Arch Neurol.1999;56:33-39) as confirmed by co-investigator neurologist, or confirmation via medical records or a letter from patient physician

Exclusion Criteria

I have had brain surgery or have malignant brain tumors.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Phase I

Participants receive tDCS+TUS combined with physical therapy for 2 weeks

2 weeks

5 visits (in-person)

Treatment Phase II

Biweekly sessions of tDCS+TUS combined with physical therapy for an additional 2 weeks

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Active tDCS and Active TUS
• Physical Therapy
• Sham TDCS and Sham TUS

Trial Overview

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.

How Is the Trial Designed?

Group I: Active tDCS and Active TUS Experimental Treatment 2 Interventions

Active tDCS and Active TUS for 20 min

Group II: Sham TDCS and Sham TUS Placebo Group 2 Interventions

Sham TDCS and Sham TUS for 20 min

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Highland Instruments, Inc.

Industry Sponsor

Trials

11

Recruited

650+

Published Research Related to This Trial

A novel telerehabilitation program using a treadmill-virtual reality system for patients with Parkinson's disease showed high adherence to training and significant improvements in walking duration, gait speed, and overall mobility over a year-long period.

The program allowed simultaneous training of two patients at home, which not only enhanced individual treatment but also saved time for therapists, making it a practical solution for maintaining exercise adherence during challenges like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-Rehabilitation with Virtual Reality: A Case Report on the Simultaneous, Remote Training of Two Patients with Parkinson Disease. Cornejo Thumm, P., Giladi, N., Hausdorff, JM., et al.[2023]

Transcranial direct current stimulation (tDCS) is a safe and non-invasive brain stimulation technique that can influence cognitive and behavioral processes, making it a potential treatment for various neuropsychiatric conditions.

The combination of tDCS with telemedicine (tele-tDCS) could enhance access to treatment for patients, particularly those with Parkinson's disease, although further research is needed to ensure safety in different clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-monitored tDCS rehabilitation: feasibility, challenges and future perspectives in Parkinson's disease. Cucca, A., Sharma, K., Agarwal, S., et al.[2020]

A four-month physical therapy program combined with drug therapy significantly improved clinical ratings and motor performance in Parkinson's patients compared to those receiving drug therapy alone.

Improvements were observed across various severity levels of symptoms and disease durations, suggesting that physical therapy is beneficial for a wide range of patients with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation and Parkinson's disease. Formisano, R., Pratesi, L., Modarelli, FT., et al.[2008]

Transcranial direct current stimulation (tDCS) showed very low quality evidence for improving motor symptoms in patients with idiopathic Parkinson's disease (IPD), specifically reducing scores on the Unified Parkinson's Disease Rating Scale (UPDRS) part III, but no significant effects on overall impairment or health-related quality of life were found.

The review included six trials with 137 participants, and while tDCS did not lead to higher dropout rates or adverse events compared to control, the overall evidence was insufficient to support its use as an effective treatment for IPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for idiopathic Parkinson's disease. Elsner, B., Kugler, J., Pohl, M., et al.[2022]

A 15-week multicomponent rehabilitation program that included water and land-based exercises significantly improved disease impact and quality of life in Parkinson's disease patients, as measured by the UPDRS and PDQ-39 scales.

Adding treadmill training to the water and land-based exercise program did not provide additional benefits for quality of life or disease impact, suggesting that the treadmill component may have limited effects in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training combined with water and land-based exercise programs: Effects on Parkinson's disease patients. Ayan, C., Varela, S., Vila, MH., et al.[2018]

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