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

NCT05268887 | Recruiting FDA Device

• 1 other identifier: 2110000486
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Immediately after completing the stimulation

• 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.

  Immediately after the completion of the stimulation

Other Outcomes (1)

• Changes in cognitive performance after gamma frequency stimulation

  baseline and immediately after the completion of the stimulation

Study Arms (2)

Parkinson's Active Arm

EXPERIMENTAL

Exposure to active sensory stimulation (40Hz) for 30-60 minutes.

Device: GENUS device (Active Settings)

Parkinson's Control Arm

SHAM COMPARATOR

Exposure to control stimulation (sham) for 30-60 minutes.

Device: GENUS device (Sham settings)

Interventions

GENUS device (Sham settings) DEVICE

Participants in the control group will use the GENUS devices configured to the sham settings for 30-60 minutes

Also known as: Gamma frequency stimulation, Light and Sound stimulation, Tactile Stimulation

Parkinson's Control Arm

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

Also known as: Gamma Frequency Stimulation, Light and Sound stimulation, Tactile stimulation

Parkinson's Active Arm

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• has undergone recent change (\<1 month) in medication
• recent drug or alcohol abuse or dependence
• laboratory results the would pose safety risk
• concurrently or has participated in other clinical trial investigation within 3 months
• pregnant
• no healthcare
• history of epilepsy, stroke, or seizure in past 24 months
• diagnosis of migraines
• have certain implantable medical devices
• contraindications for MRI
• life expectancy of less than 2 years

Sponsors & Collaborators

• Massachusetts Institute of Technology: lead

Study Sites (1)

Massachusetts Institute of Technology

Cambridge, Massachusetts, 02139, United States

RECRUITING

Related Publications (9)

• Brown P. Oscillatory nature of human basal ganglia activity: relationship to the pathophysiology of Parkinson's disease. Mov Disord. 2003 Apr;18(4):357-63. doi: 10.1002/mds.10358.

  PMID: 12671940 BACKGROUND

• Brown P, Oliviero A, Mazzone P, Insola A, Tonali P, Di Lazzaro V. Dopamine dependency of oscillations between subthalamic nucleus and pallidum in Parkinson's disease. J Neurosci. 2001 Feb 1;21(3):1033-8. doi: 10.1523/JNEUROSCI.21-03-01033.2001.

  PMID: 11157088 BACKGROUND

• Deuschl G, Schade-Brittinger C, Krack P, Volkmann J, Schafer H, Botzel K, Daniels C, Deutschlander A, Dillmann U, Eisner W, Gruber D, Hamel W, Herzog J, Hilker R, Klebe S, Kloss M, Koy J, Krause M, Kupsch A, Lorenz D, Lorenzl S, Mehdorn HM, Moringlane JR, Oertel W, Pinsker MO, Reichmann H, Reuss A, Schneider GH, Schnitzler A, Steude U, Sturm V, Timmermann L, Tronnier V, Trottenberg T, Wojtecki L, Wolf E, Poewe W, Voges J; German Parkinson Study Group, Neurostimulation Section. A randomized trial of deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Aug 31;355(9):896-908. doi: 10.1056/NEJMoa060281.

  PMID: 16943402 BACKGROUND

• Heusinkveld LE, Hacker ML, Turchan M, Davis TL, Charles D. Impact of Tremor on Patients With Early Stage Parkinson's Disease. Front Neurol. 2018 Aug 3;9:628. doi: 10.3389/fneur.2018.00628. eCollection 2018.

  PMID: 30123178 BACKGROUND

• Kogan M, McGuire M, Riley J. Deep Brain Stimulation for Parkinson Disease. Neurosurg Clin N Am. 2019 Apr;30(2):137-146. doi: 10.1016/j.nec.2019.01.001.

  PMID: 30898266 BACKGROUND

• Litvak V, Eusebio A, Jha A, Oostenveld R, Barnes G, Foltynie T, Limousin P, Zrinzo L, Hariz MI, Friston K, Brown P. Movement-related changes in local and long-range synchronization in Parkinson's disease revealed by simultaneous magnetoencephalography and intracranial recordings. J Neurosci. 2012 Aug 1;32(31):10541-53. doi: 10.1523/JNEUROSCI.0767-12.2012.

  PMID: 22855804 BACKGROUND

• Muthuraman M, Bange M, Koirala N, Ciolac D, Pintea B, Glaser M, Tinkhauser G, Brown P, Deuschl G, Groppa S. Cross-frequency coupling between gamma oscillations and deep brain stimulation frequency in Parkinson's disease. Brain. 2020 Dec 5;143(11):3393-3407. doi: 10.1093/brain/awaa297.

  PMID: 33150359 BACKGROUND

• Okun MS. Deep-brain stimulation for Parkinson's disease. N Engl J Med. 2012 Oct 18;367(16):1529-38. doi: 10.1056/NEJMct1208070. No abstract available.

  PMID: 23075179 BACKGROUND

• Okun MS, Fernandez HH, Wu SS, Kirsch-Darrow L, Bowers D, Bova F, Suelter M, Jacobson CE 4th, Wang X, Gordon CW Jr, Zeilman P, Romrell J, Martin P, Ward H, Rodriguez RL, Foote KD. Cognition and mood in Parkinson's disease in subthalamic nucleus versus globus pallidus interna deep brain stimulation: the COMPARE trial. Ann Neurol. 2009 May;65(5):586-95. doi: 10.1002/ana.21596.

  PMID: 19288469 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Li-Huei Tsai, PhD

  Massachusetts Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gamma wave

CONTACT

617-258-7723; gamma.wave@mit.edu

Ana Trisini Lipsanopoulos, BS

CONTACT

617-258-7723; anat13@mit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: March 7, 2022
• Study Start: February 9, 2022
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)