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Behavioural Intervention

Gamma Wave Stimulation for Parkinson's Disease

N/A
Recruiting
Led By Diane Chan, PhD
Research Sponsored by Massachusetts Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has Idiopathic PD defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor or rigidity and without any other known or suspected cause of Parkinsonism (according to Movement disorder society (MDS) clinical diagnostic criteria for Parkinson's disease confirmed by a fellowship trained movements disorder specialist
Subject is > 45 and <90 years of age
Must not have
Diagnosis of migraines
Subject has atypical Parkinson's syndrome(s) due to drugs, metabolic neurogenetic disorders (e.g., Wilson's Disease), encephalitis, cerebrovascular disease, or degenerative disease (e.g., Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, Lewy Body dementia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and immediately after the completion of the stimulation

Summary

This trial is testing a method of increasing gamma brain waves in people with Parkinson's disease to see if it is safe, feasible, and helpful.

Who is the study for?
This trial is for people aged 45-90 with mild Parkinson's disease, who are at Hoehn & Yahr stage 2 to 3. Participants must be stable on their current Parkinson's medications and have a MOCA score ≥26. They should not have any other neurological conditions or recent changes in medication, and cannot be pregnant or have had seizures recently.
What is being tested?
The GENUS device is being tested to see if it can improve motor and cognitive deficits in Parkinson's by using light, sound, and tactile stimulation. The study will involve EEG monitoring of brain waves before, during, and after the use of the device to assess its safety and effectiveness.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from sensory stimulation or unforeseen reactions due to the novel nature of this therapy. Safety assessments will monitor for adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Parkinson's disease by a specialist.
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I am between 45 and 90 years old.
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My Parkinson's disease is at a moderate stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with migraines.
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I have a Parkinson's-like condition not caused by typical Parkinson's disease.
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I am not on sedatives that my doctor says I shouldn't take.
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I have not had epilepsy, stroke, or a seizure in the last 2 years.
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I have been diagnosed with dementia or another neurological condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after completing the stimulation
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after completing the stimulation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of gamma frequency stimulation
Incidence of Stimulation-Related Adverse Events
Other study objectives
Changes in cognitive performance after gamma frequency stimulation

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Parkinson's Active ArmExperimental Treatment1 Intervention
Exposure to active sensory stimulation (40Hz) for 30-60 minutes.
Group II: Parkinson's Control ArmPlacebo Group1 Intervention
Exposure to control stimulation (sham) for 30-60 minutes.

Find a Location

Who is running the clinical trial?

Massachusetts Institute of TechnologyLead Sponsor
98 Previous Clinical Trials
12,819,947 Total Patients Enrolled
Diane Chan, PhDPrincipal InvestigatorMassachusetts Institute of Technology
Li-Huei Tsai, PhDPrincipal InvestigatorMassachusetts Institute of Technology
3 Previous Clinical Trials
155 Total Patients Enrolled

Media Library

GENUS device (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05268887 — N/A
~11 spots leftby Nov 2025
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