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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

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 40 and 90 years old.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in postural sway

Secondary outcome measures

Arising from a chair

Balance

Gait

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCS and Active TUSExperimental Treatment2 Interventions

Active tDCS and Active TUS for 20 min

Group II: Sham TDCS and Sham TUSPlacebo Group2 Interventions

Sham TDCS and Sham TUS for 20 min

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor

135 Previous Clinical Trials

11,015 Total Patients Enrolled

Highland Instruments, Inc.Industry Sponsor

10 Previous Clinical Trials

513 Total Patients Enrolled

Felipe Fregni, MD, PhDPrincipal Investigator - Spaulding Rehabilitation Hospital

Spaulding Rehabilitation Hospital

5 Previous Clinical Trials

148 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I qualify to participate in this medical research?

"This medical research is looking for 40 subjects aged between 40 and 90 with a Parkinson's disease diagnosis, who have also been on stable medication for at least 30 days. Additionally, participants need to display symptoms of postural instability or balance impairment due to PD as per the Gelb D et al. Diagnostic Criteria (1999)."

Answered by AI

Is this investigation enrolling senior citizens in its research?

"The requirements to enter this study dictate that the patient must be between 40 and 90 years old. Additionally, there are 27 studies available for underage patients while 485 trials accommodate seniors above 65."

Answered by AI

Is this experiment currently seeking participants?

"According to clinicaltrials.gov, this medical trial is currently enlisting participants. It's initial posting occurred on January 23rd 2020 and it was most recently revised on August 12th 2022."

Answered by AI

How many individuals are being included in this experiment?

"Affirmative, the clinicaltrials.gov portal reveals that this experiment is currently seeking participants. The trial was first announced on January 23rd 2020 and has been recently modified as of August 12th 2022. 40 individuals are required at a single medical centre to take part in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability.

Felipe Fregni, MD, PhD, MPH 2020. "Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03981055.

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