Gamma Frequency Stimulation for Down Syndrome
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts Institute of Technology
Must not be taking: Anti-epileptics, Antidepressants, Antipsychotics, others
Disqualifiers: Autism, Seizure, Stroke, Migraine, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
Down Syndrome (DS) is characterized by an additional copy of chromosome 21, which also increases risk of Alzheimer's Disease (AD). The investigators' lab found a non-invasive way to remove toxic proteins from the brain in AD mouse models. Remarkably, treated mice also have improved memory on behavioral testing. The investigators then translated this non-invasive method, which uses light and sound to stimulate the brain, to be used in mild Alzheimer's patients and cognitively normal adults. The investigators have also translated this research into a vibrating speaker device to study tactile vibration to stimulate the brain as well. For the present study, 30 participants with Down Syndrome and 30 cognitively normal adult controls will be recruited, and the investigators will assess their brain waves with electroencephalogram (EEG) during light, sound, and tactile stimulation. The investigators will also test for safety, feasibility, and cognitive performance before and after a 30-60 minute session of light and sound stimulation to optimize the stimulation devices for use in the DS population.
Will I have to stop taking my current medications?
The trial requires that participants have been on consistent medication for the previous 3 months, so you should not stop taking your current medications. However, if you are on certain medications like anti-epileptic or psychiatric agents, you may not be eligible to participate.
What data supports the effectiveness of the treatment GENUS device, 40Hz Light and Sound Therapy, Gamma Light Therapy, GENUS device for Down Syndrome?
There is no direct evidence from the provided research articles about the effectiveness of the GENUS device or 40Hz Light and Sound Therapy for Down Syndrome. However, one study mentions that transcranial direct current stimulation (a different type of brain stimulation) combined with virtual reality training has shown promise in improving functional and sensory skills in children with Down syndrome, suggesting that brain stimulation therapies might have potential benefits.12345
How is the GENUS device treatment different from other treatments for Down Syndrome?
The GENUS device is unique because it uses non-invasive light and sound therapy at a specific gamma frequency (40 Hz) to potentially improve brain function, unlike traditional treatments that may focus on medication or behavioral therapy. This approach is novel as it aims to modulate brain activity through sensory stimulation, which is being explored for its effects on conditions like Alzheimer's and Parkinson's diseases.678910
Eligibility Criteria
This trial is for adults aged 25-65 with Down Syndrome, who are medically stable and have not changed medications in the last 3 months. They must be able to give consent or have a guardian do so. Excluded are those with recent strokes, migraines, untreated ADHD, certain medication use (like Wellbutrin), significant psychiatric risks, behavioral issues affecting protocol adherence, active medical implants, severe sensory impairments, pregnancy, autism co-diagnosis or recent seizures.Inclusion Criteria
I have been diagnosed with Down Syndrome, not the mosaic type.
If I can't consent, someone legally allowed will do it for me.
I am between 25 and 65 years old.
See 2 more
Exclusion Criteria
I have had a stroke in the last 2 years.
You have a medical device implanted in your body, such as a pacemaker or neurostimulator.
I have severe hearing or vision loss that cannot be corrected.
See 10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Stimulation Session
Participants undergo a 30-60 minute session of light and sound stimulation to assess brain wave entrainment and cognitive performance
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness immediately after stimulation
Immediately after stimulation
1 visit (in-person)
Treatment Details
Interventions
- GENUS device (Behavioural Intervention)
Trial OverviewThe study tests a non-invasive GENUS device that uses light and sound to stimulate the brain. It aims to improve cognitive function by removing toxic proteins associated with Alzheimer's Disease risk in people with Down Syndrome. Participants will undergo EEGs during stimulation sessions to measure brain waves and assess safety and cognitive effects.
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Down Syndrome ExperimentalExperimental Treatment1 Intervention
Experimental arm within Down Syndrome participant group: exposure to active 40Hz stimulation for 30-60 minutes.
Group II: Cognitively Normal ExperimentalExperimental Treatment1 Intervention
Experimental arm within the cognitively normal control participant group: exposure to active 40Hz stimulation for 30-60 minutes.
Group III: Down Syndrome ShamPlacebo Group1 Intervention
Sham arm within the Down Syndrome participant group: exposure to control stimulation for 30-60 minutes.
Group IV: Cognitively Normal ShamPlacebo Group1 Intervention
Sham arm within the cognitively normal control participant group: exposure to control stimulation for 30-60 minutes.
GENUS device is already approved in United States for the following indications:
🇺🇸 Approved in United States as 40Hz Light and Sound Therapy for:
- Alzheimer's disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts Institute of TechnologyCambridge, MA
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Who Is Running the Clinical Trial?
Massachusetts Institute of TechnologyLead Sponsor
References
Comparison of different therapy approaches in children with Down syndrome. [2019]Children with Down syndrome have sensory integrative dysfunction as a result of limited sensory experience from lack of normal motor control. The aim of the present study was to compare the effects of sensory integrative therapy alone, vestibular stimulation in addition to sensory integrative therapy and neurodevelopmental therapy, on children with Down syndrome.
Delays in Motor Development in Children with Down Syndrome. [2018]Children with Down syndrome (DS) present with delays in motor development. The reduced size of the cerebrum, brain maturation disorders, and pathophysiological processes lead to motor development delay. The aim of this study was to examine the gross motor function and estimate what motor abilities are significantly delayed in children with Down syndrome even if they attend physical therapy sessions. Another purpose of the study was to assess the functional balance.
Opportunities, barriers, and recommendations in down syndrome research. [2023]Recent advances in medical care have increased life expectancy and improved the quality of life for people with Down syndrome (DS). These advances are the result of both pre-clinical and clinical research but much about DS is still poorly understood. In 2020, the NIH announced their plan to update their DS research plan and requested input from the scientific and advocacy community.
Minimal Detectable Change for TUG and TUDS Tests for Children With Down Syndrome. [2018]To determine test-retest reliability and minimal detectable change of the Timed Up and Go (TUG) and Timed Up and Down Stairs (TUDS) for Down syndrome.
Brain activity and upper limb movement analysis in children with Down syndrome undergoing transcranial direct current stimulation combined with virtual reality training: study protocol for a randomized controlled trial. [2023]Children with Down syndrome have poorer functional and sensory skills compared to children with typical development. Virtual reality (VR) training could help improve these skills. Moreover, transcranial direct current stimulation (tDCS) has achieved promising results in terms of enhancing the effects of physical and sensory therapy by modulating cortical excitability.
Gamma Band Neural Stimulation in Humans and the Promise of a New Modality to Prevent and Treat Alzheimer's Disease. [2019]Existing treatments for Alzheimer's disease (AD) have questionable efficacy with a need for research into new and more effective therapies to both treat and possibly prevent the condition. This review examines a novel therapeutic modality that shows promise for treating AD based on modulating neuronal activity in the gamma frequency band through external brain stimulation. The gamma frequency band is roughly defined as being between 30 Hz-100 Hz, with the 40 Hz point being of particular significance. The epidemiology, diagnostics, existing pathological models, and related current treatment targets are initially briefly reviewed. Next, the concept of external simulation triggering brain activity in the gamma band with potential demonstration of benefit in AD is introduced with reference to a recent important study using a mouse model of the disease. The review then presents a selection of relevant studies that describe the neurophysiology involved in brain stimulation by external sources, followed by studies involving application of the modality to clinical scenarios. A table summarizing the results of clinical studies applied to AD patients is also reported and may aid future development of the modality. The use of a therapy based on modulation of gamma neuronal activity represents a novel non-invasive, non-pharmacological approach to AD. Although use in clinical scenarios is still a relatively recent area of research, the technique shows good signs of efficacy and may represent an important option for treating AD in the future.
Non-invasive auditory and visual stimulation attenuates α-Synuclein deposition and improves motor and non-motor symptoms in PD mice. [2023]Parkinson's disease (PD) is characterized by dopaminergic neuron loss and α-synuclein (α-Syn) aggregates, but lacks effective treatments for the disease progression and non-motor symptoms. Recently, combined 40 Hz auditory and visual stimulation is emerging as a promising non-invasive method to decrease amyloid and improve cognition in Alzheimer's disease (AD), but whether this treatment can modify α-Syn-induced PD pathology remains unclear. Here we evaluated the effects of chronic exposure to 40 Hz and 80 Hz auditory and visual stimulation on α-Syn accumulation and the functional effects of 40 Hz stimulation on motor, cognitive and mood dysfunctions in PD mice. We found that 40 Hz and 80 Hz auditory and visual stimulation activated multiple cortical regions, entrained gamma oscillations and markedly attenuated p-α-Syn deposition in neurons, but not astrocytes, microglial cells in the primary and secondary motor cortex (M1, M2), medial prefrontal cortex (mPFC) and the striatum. Moreover, 40 Hz stimulation significantly reduced cell apoptosis in M1, increased the neuromuscular strength selectively in PD mice, which correlated with p-α-Syn reduction in the motor cortex. In addition, 40 Hz stimulation improved spatial working memory and decreased depressive-like behaviors specifically in PD mice, which correlated with p-α-Syn reduction in mPFC, but promoted anxiety-like behaviors and increased stress-related adreno-cortico-tropic-hormone (ACTH), corticosterone levels in the plasma of normal mice. Collectively, we demonstrated that chronic multisensory gamma stimulation (40 Hz and 80 Hz) significantly attenuates α-Syn deposition in neurons of the interconnected cortex and 40 Hz stimulation improved neuromuscular strength, spatial working memory, and reduced depressive behaviors, which support its non-invasive therapeutic potential for modifying PD progression and treating non-motor symptoms.
Photobiological Neuromodulation of Resting-State EEG and Steady-State Visual-Evoked Potentials by 40 Hz Violet Light Optical Stimulation in Healthy Individuals. [2021]Photobiological neuromodulation and its clinical application has been investigated in recent years. The response of the gamma-oscillation to human visual stimuli is known to be both burst and resonant in nature, and the coupling between alpha and gamma oscillations may play a functional role in visual processing. To date, there is no study that examined the effects of gamma-frequency violet light (VL) stimulation on human electroencephalography (EEG). In this study, we investigated the neurophysiological changes induced by light stimulation using EEG. The purpose of this study was to evaluate the specific effects of 40 Hz gamma-frequency VL stimulation on EEG activity by comparing the effects of white light (WL) with the same condition. Twenty healthy participants (10 females: 37.5 ± 14.3 years; 10 males: 38.0 ± 13.3 years) participated in this study and the following results were observed. First, when compared with the power spectrum density (PSD) of baseline EEG, 40 Hz-WL induced significant increase of PSD in theta band. Second, compared the PSDs between EEG with 40 Hz-VL and EEG with 40 Hz-WL, 40 Hz-VL induced significantly lower enhancement in delta and theta bands than 40 Hz-WL. Third, when focused on the occipital area, negative peak of VEP with 40 Hz-VL was smaller than that of 40 Hz-WL. Fourth, 40 Hz-VL induced an increase of alpha-gamma coupling during the VEP at the F5 electrode site as well as post-EEG at the C4 electrode site, compared with baseline EEG. Thus, the present study suggested that 40 Hz-VL stimulation may induce unique photobiological neuromodulations on human EEG activity.
An update on the use of gamma (multi)sensory stimulation for Alzheimer's disease treatment. [2023]Alzheimer's disease (AD) is characterized by reduced fast brain oscillations in the gamma band (γ, > 30 Hz). Several animal studies show that inducing gamma oscillations through (multi)sensory stimulation at 40 Hz has the potential to impact AD-related cognitive decline and neuropathological processes, including amyloid plaques deposition, neurofibrillary tangles formation, and neuronal and synaptic loss. Therefore Gamma Entrainment Using Sensory stimulation (GENUS) is among the most promising approaches for AD patients' treatment. This review summarizes the evidence on GENUS effectiveness, from animal models to AD patients. Despite the application on human is in its infancy, the available findings suggest its feasibility for the treatment of AD. We discuss such results in light of parameter improvement and possible underlying mechanisms. We finally emphasize the need for further research for its development as a disease-modifying non-pharmacological intervention.
A feasibility trial of gamma sensory flicker for patients with prodromal Alzheimer's disease. [2022]We and collaborators discovered that flickering lights and sound at gamma frequency (40 Hz) reduce Alzheimer's disease (AD) pathology and alter immune cells and signaling in mice. To determine the feasibility of this intervention in humans we tested the safety, tolerability, and daily adherence to extended audiovisual gamma flicker stimulation.