RECRUITING

High Frequency Light, Sound, and Tactile Stimulation to Improve Motor and Cognitive Deficits in Parkinson's Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Acute Treatment of Parkinson's Disease With Gamma Frequency Stimulation

Quick Facts

Study Start:2022-02-09
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05268887

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Subject is Hoehn \& Yahr stage 2 to 3
  3. * Subject has a Montreal Cognitive Assessment (MOCA) score ≥26.
  4. * Subject is \> 45 and \<90 years of age.
  5. * proficient in speaking, reading, and understanding English
  6. * capable of providing informed written consent
  7. * 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.
  8. * Subject has undergone a brain CT or MRI prior to rule out underlying structural lesions
  1. * 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)
  2. * history of any psychiatric illness that would pose a safety risk
  3. * diagnosis of dementia or other neurological conditions
  4. * currently taking sedative medications that are clinically contraindicated
  5. * has undergone recent change (\<1 month) in medication
  6. * recent drug or alcohol abuse or dependence
  7. * laboratory results the would pose safety risk
  8. * concurrently or has participated in other clinical trial investigation within 3 months
  9. * pregnant
  10. * no healthcare
  11. * history of epilepsy, stroke, or seizure in past 24 months
  12. * diagnosis of migraines
  13. * have certain implantable medical devices
  14. * contraindications for MRI
  15. * life expectancy of less than 2 years

Contacts and Locations

Study Contact

MJ Quay, MS
CONTACT
617-258-7723
mcolburn@mit.edu
Janna Hong, BS
CONTACT
617-258-7723
dchan5@mgb.org

Principal Investigator

Li-Huei Tsai, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts Institute of Technology
Diane Chan, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts Institute of Technology

Study Locations (Sites)

Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
United States

Collaborators and Investigators

Sponsor: Massachusetts Institute of Technology

  • Li-Huei Tsai, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts Institute of Technology
  • Diane Chan, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts Institute of Technology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-09
Study Completion Date2025-11

Study Record Updates

Study Start Date2022-02-09
Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

  • Parkinson's Disease
  • Motor Impairment
  • Non-Invasive Sensory Stimulation
  • Light and Sound Stimulation
  • Tactile Stimulation
  • Gamma

Additional Relevant MeSH Terms

  • Parkinson Disease