Parkinson's Disease Clinical Trials

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Acute Treatment of Parkinson's Disease With Gamma Frequency Stimulation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Parkinson's disease (PD) impacts different types of neural oscillations in the brain, including beta (13-30Hz) and gamma oscillations (30-80Hz), which contributes to PD's cardinal symptoms of resting tremor, rigidity, bradykinesia (slowness of movement), and gait instability. The investigators' lab has developed a non-invasive method of increasing gamma power in the brain using Gamma Entrainment Using Sensory Stimulation (GENUS) through light, sound, and tactile stimulation devices. For this study, 40 participants with mild Parkinson's disease will be recruited, and the investigators will assess their brain waves with electroencephalogram (EEG) before, during, and after light, sound, and tactile stimulation to determine the safety, feasibility, and optimization of GENUS as a potential therapy in the PD population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 90
Healthy Volunteers: f
View:

• 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 Hoehn \& Yahr stage 2 to 3

• Subject has a Montreal Cognitive Assessment (MOCA) score ≥26.

• Subject is \> 45 and \<90 years of age.

• proficient in speaking, reading, and understanding English

• capable of providing informed written consent

• Subject is on a stable dose (at least 1 month prior to baseline visit) of antiparkinsonian agents and willing to remain on this dose for the duration of the study. If on a cholinesterase inhibitor, a stable dose without changes for 1 month is required.

• Subject has undergone a brain CT or MRI prior to rule out underlying structural lesions

Locations
United States
Massachusetts
Massachusetts Institute of Technology
RECRUITING
Cambridge
Contact Information
Primary
MJ Quay, MS
mcolburn@mit.edu
617-258-7723
Backup
Remi Philips, BS
remip@mit.edu
617-258-7723
Time Frame
Start Date: 2022-02-09
Estimated Completion Date: 2025-11
Participants
Target number of participants: 40
Treatments
Experimental: Parkinson's Active Arm
Exposure to active sensory stimulation (40Hz) for 30-60 minutes.
Sham_comparator: Parkinson's Control Arm
Exposure to control stimulation (sham) for 30-60 minutes.
Authors
Vanesa Fernandez
Related Therapeutic Areas
Sponsors
Leads: Massachusetts Institute of Technology

This content was sourced from clinicaltrials.gov