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Behavioural Intervention

Gamma Wave Stimulation for Parkinson's Disease

N/A
Recruiting
Led By Li-Huei Tsai, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and immediately after the completion of the stimulation
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of gamma frequency stimulation
Incidence of Stimulation-Related Adverse Events
Other outcome measures
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
97 Previous Clinical Trials
12,729,947 Total Patients Enrolled
Li-Huei Tsai, PhDPrincipal InvestigatorMassachusetts Institute of Technology
3 Previous Clinical Trials
155 Total Patients Enrolled
Diane Chan, PhDPrincipal InvestigatorMassachusetts Institute of Technology

Media Library

GENUS device (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05268887 — N/A

Frequently Asked Questions

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

Are there any particular demographics that are best suited for participating in this research study?

"This clinical trial is seeking 40 people with idiopathic Parkinson's disease between the ages of 45 and 90. In order to be a successful candidate, they must meet certain criteria such as: being Hoehn & Yahr stage 2-3; having a Montreal Cognitive Assessment (MOCA) score of at least 26 points; speaking, reading and understanding English fluently; providing informed written consent for study participation; getting an MRI or CT scan before recruitment to rule out any structural lesions in the brain; maintaining stable doses of antiparkinsonian medications for one month prior to baseline visit."

Answered by AI

How many participants have been accepted into this research endeavor?

"Yes, according to the information on clinicaltrials.gov this trial is currently accepting participants. It was first posted on February 9th 2022 and last updated February 24th 2022. 40 patients across one medical centre must be recruited for the study's completion."

Answered by AI

Does this research encompass individuals aged sixty or above?

"This medical trial has set the age range for eligible participants to be between 45 and 90. For those younger than 18 years of age, there are 27 studies available whereas 487 studies exist for those older than 65."

Answered by AI

Does this research currently have any open recruitment slots?

"Affirmative. According to clinicaltrials.gov, this research endeavour is still actively seeking out potential participants. It was first registered on February 9th 2022 and the last update took place on February 24th 2022. The study requires 40 recruits from a single medical centre for completion."

Answered by AI
Recent research and studies
~7 spots leftby Nov 2024