High Frequency Light, Sound, and Tactile Stimulation to Improve Motor and Cognitive Deficits in Parkinson's Disease
NCT ID: NCT05268887
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
40 participants
INTERVENTIONAL
2022-02-09
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Investigators hypothesize that boosting gamma oscillations using 40Hz GENUS will augment movement and improve tremor and bradykinesia in PD patients. Thus, the purpose of this study is to determine whether gamma entrainment through non-invasive 40Hz sensory stimulation can be observed in patients with PD as measured by electroencephalogram (EEG) during an acute stimulation session. Investigators also hope to determine whether the GENUS devices are safe and easy to use in the PD population.
The investigators will recruit 40 participants diagnosed with mild PD who will be randomly assigned to two study arms: control stimulation and active 40Hz stimulation. Participants will be asked to do a series of movement exercises while wearing an actigraphy watch that tracks their activity before the stimulation session. Cognitive and mental health evaluations and memory tests will also be performed on all participants before and after exposure to the GENUS devices, which can deliver light, sound, and tactile waves at different frequencies. The first GENUS device is composed of a panel with light-emitting diode (LED) illumination and speakers for auditory stimulation, whilst the second device is composed of a small vibrating speaker for tactile stimulation. Each of the two groups will have different combinations of light, sound, and tactile settings.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Parkinson's Active Arm
Exposure to active sensory stimulation (40Hz) for 30-60 minutes.
GENUS device (Active Settings)
Participants in the active, experimental group will use the GENUS devices configured to active (40Hz) setting for 30-60 minutes
Parkinson's Control Arm
Exposure to control stimulation (sham) for 30-60 minutes.
GENUS device (Sham settings)
Participants in the control group will use the GENUS devices configured to the sham settings for 30-60 minutes
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GENUS device (Active Settings)
Participants in the active, experimental group will use the GENUS devices configured to active (40Hz) setting for 30-60 minutes
GENUS device (Sham settings)
Participants in the control group will use the GENUS devices configured to the sham settings for 30-60 minutes
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
45 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Massachusetts Institute of Technology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Li-Huei Tsai, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts Institute of Technology
Diane Chan, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts Institute of Technology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
MJ Quay, MS
Role: primary
Remi Philips, BS
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2110000486
Identifier Type: -
Identifier Source: org_study_id