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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-90
SponsorMassachusetts Institute of Technology

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

history of any psychiatric illness that would pose a safety risk

diagnosis of dementia or other neurological conditions

currently taking sedative medications that are clinically contraindicated

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Parkinson's Active ArmExperimental treatment 1 intervention
Group B: Parkinson's Control ArmSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of gamma frequency stimulation

Feasibility of gamma frequency stimulation in subjects with mild PD will be assessed by analyzing the EEG data from each subject for a sign of change in gamma frequency waves and determining the percent of subjects who show this change.

Time frame
Immediately after completing the stimulation
2

Incidence of Stimulation-Related Adverse Events

Tolerability and safety of gamma frequency stimulation will be assessed by using a questionnaire asking for the subjects' overall experience with the stimulation and denoting any adverse effects.

Time frame
Immediately after the completion of the stimulation

Secondary outcomes

Other outcomes

1

Changes in cognitive performance after gamma frequency stimulation

Exploratory measure to check if there is any change in cognitive performance, between baseline and immediately after the completion of stimulation. The CANTAB testing battery will be used to test for attention, memory, psychomotor speed, and executive function.

Time frame
baseline and immediately after the completion of the stimulation

Sponsors and contacts

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