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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Brain Stimulation + Physical Therapy for Parkinson's Disease?

Research shows that combining transcranial direct current stimulation (tDCS) with physical therapy can improve walking ability in Parkinson's patients. Additionally, physical therapy alone has been shown to enhance motor performance and functional abilities in these patients, suggesting that it is a valuable part of comprehensive treatment. ^{1 2 3 4 5}

Is brain stimulation combined with physical therapy safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe when used within standardized protocols in research or clinical settings. It has been studied in both healthy individuals and those with various brain disorders, showing potential as a safe complementary treatment, especially when combined with other therapies like physical therapy. ^{3 6 7 8 9}

How does the treatment of brain stimulation and physical therapy for Parkinson's disease differ from other treatments?

This treatment combines non-invasive brain stimulation techniques, like transcranial direct current stimulation (tDCS) and transcranial ultrasound stimulation (TUS), with physical therapy to enhance motor function and potentially offer neuroprotective benefits. Unlike traditional drug therapies, this approach focuses on improving neural reorganization and recovery through physical and brain stimulation, which may provide longer-lasting improvements in motor abilities. ^{1 4 10 11 12}

What is the purpose of this trial?

This trial aims to understand the mechanism and to test whether transcranial direct current stimulation (tDCS) combined with transcranial ultrasound (TUS) (tDCS+TUS) combined with physical therapy (PT) will induce significant therapeutic effects in postural instability in Parkinson's disease (PT) patients. The investigators designed a double-blinded, placebo controlled, randomized study to investigate the effects of 2 weeks of TDCS+TUS on postural instability in PD patients receiving PT. (Followed by biweekly sessions for 2 more weeks in Phase II)

Research Team

Felipe Fregni, MD, PhD, MPH

Principal Investigator

Spaulding Rehabilitation Hospital

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Highland Instruments, Inc.

Industry Sponsor

Trials

11

Recruited

650+

Findings from Research

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Transcranial Direct Current Stimulation Plus Physical Therapy on Gait in Patients With Parkinson Disease: A Randomized Controlled Trial. [2017]

2. Sweden pubmed.ncbi.nlm.nih.gov

Rehabilitation and Parkinson's disease. [2008]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Acute effects of transcranial direct current stimulation combined with physical therapy on the balance and gait in individuals with Parkinson's disease: A randomized controlled trial. [2023]

4. France pubmed.ncbi.nlm.nih.gov

[Neurorehabilitation in parkinsonian syndromes]. [2010]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Treadmill training combined with water and land-based exercise programs: Effects on Parkinson's disease patients. [2018]

6. Italy pubmed.ncbi.nlm.nih.gov

Repeated sessions of transcranial direct current stimulation evaluation on fatigue and daytime sleepiness in Parkinson's disease. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Tele-monitored tDCS rehabilitation: feasibility, challenges and future perspectives in Parkinson's disease. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Can Task Specificity Impact tDCS-Linked to Dual Task Training Gains in Parkinson's Disease? A Protocol for a Randomized Controlled Trial. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS). [2022]

10. England pubmed.ncbi.nlm.nih.gov

Intermittent theta-burst stimulation combined with physical therapy as an optimal rehabilitation in Parkinson's disease: study protocol for a randomised, double-blind, controlled trial. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for idiopathic Parkinson's disease. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Tele-Rehabilitation with Virtual Reality: A Case Report on the Simultaneous, Remote Training of Two Patients with Parkinson Disease. [2023]