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

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Massachusetts Institute of Technology
Study ID
NCT05268887
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • GENUS device (Active Settings) — DEVICE
    Participants in the active, experimental group will use the GENUS devices configured to active (40Hz) setting for 30-60 minutes
  • GENUS device (Sham settings) — DEVICE
    Participants in the control group will use the GENUS devices configured to the sham settings for 30-60 minutes

Study Details

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.

Key Dates

Start date
Feb 9, 2022
Status verified
Mar 2026
Primary completion
Nov 1, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Feasibility of gamma frequency stimulation [ Time Frame: Immediately after completing the stimulation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Institute of TechnologyCambridgeMassachusetts02139
Ana Trisini Lipsanopoulos, BS
617-258-7723
Li-Huei Tsai, PhD (PRINCIPAL_INVESTIGATOR)
Ute Geigenmuller, PhD (SUB_INVESTIGATOR)
Ana Trisini Lipsanopoulos, BS (SUB_INVESTIGATOR)

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