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Subarachnoid Hemorrhage, AneurysmalGES-aSAHNCT06346015

Gamma Entrainment Stimulation for Cognitive Dysfunction After aSAH

A study testing Gamma Entrainment Stimulation in people with Subarachnoid Hemorrhage, Aneurysmal and Cognitive Dysfunction, run by Beijing Tiantan Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to Explore and verify whether 40Hz audio and binaural beat 40Hz audio can improve the postoperative cognitive dysfunction seen in patients with aneurysmal subarachnoid hemorrhage. This study is a single-center, prospective, randomized, controlled clinical trial. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Gamma Entrainment Stimulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Apr 2024to 31 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of aneurysmal subarachnoid hemorrhage and aneurysm secured
  • Postoperative TAPS score ≥ 2 points
  • Age: 18 years old and 75 years old
  • Hearing function is not impaired and audio therapy is well tolerated
  • informed Consented

Who cannot join

  • Hearing impairment or significant discomfort with audio therapy
  • In other clinical trials within three months before the trial
  • Pregnant women and lactating women
  • Drugs that may affect cognitive function should be used during the study
  • Previous history including cognitive dysfunction or mental illness

Trial locations and contacts

No sites are listed yet.

Runting Li, MD contact

tt18080lrt@163.com

About this study

Official title: Efficacy of Gamma Entrainment Stimulation for Cognitive Dysfunction After Aneurysmal Subarachnoid Hemorrhage: a Prospective Randomized Controlled Trial

The goal of this clinical trial is to Explore and verify whether 40Hz audio and binaural beat 40Hz audio can improve the postoperative cognitive dysfunction seen in patients with aneurysmal subarachnoid hemorrhage. This study is a single-center, prospective, randomized, controlled clinical trial. Patients with aneurysmal subarachnoid hemorrhage were selected and randomized into intervention group (audio adjuvant group) and control group (conventional treatment group). Patients in the intervention group will receive audio therapy after surgery, and patients in the control group will receive usual care. EEG, fMRI and mRS scores were evaluated after 3 months of follow-up.

Read the detailed description

Aneurysmal subarachnoid hemorrhage (aSAH) is a neurological malady that has garnered global public health apprehension due to its severity. Research indicates that cerebral ischemic events subsequent to aSAH treatment are both pervasive and intricate, with their occurrence mechanism and timing categorized into early and late onset. Early cerebral ischemia typically manifests within 1-3 days post-aSAH onset, primarily attributed to factors such as cerebral vasospasm, hemorrhagic cerebral edema, and thrombosis. The severity of these lesions can be alleviated through medical, endovascular, and surgical interventions. Conversely, delayed cerebral ischemia generally arises between 4 days to 2 weeks after surgery, predominantly stemming from cerebral edema, inflammatory reactions, cortical depolarization, and microthrombosis. Managing delayed cerebral ischemia necessitates vigilant patient monitoring and the maintenance of stable cerebral blood flow, achieved by mitigating the impact of cerebral edema and inflammatory responses. Cerebral ischemia induces physiological changes like nerve cell damage, apoptosis, glial cell proliferation, and inflammatory responses, potentially impacting brain function, particularly cognitive function. Consequently, the application of our established TAPS prognostic model effectively identifies individuals at a higher risk of cognitive dysfunction and poor prognosis, facilitating the screening of potential intervention candidates for this study.

In recent years, the scientific community has discerned the pivotal role of microglia in preserving the stability of the brain environment. By modulating their activities, the degree of ischemia can be effectively controlled, mitigating subsequent impairments in brain function. This revelation forms the basis for pioneering nonpharmacological treatment strategies. Among these innovative approaches, frequency-specific audio therapy, notably utilizing 40Hz audio and binaural beat audio, has garnered significant attention. 40Hz audio induces gamma waves in the brain, linked to cognitive functions such as attention, memory, and perception. Binaural beat audio, a neuroacoustic phenomenon, involves introducing two sounds with slightly different frequencies to the ears, prompting the brain to create a new EEG frequency. Regarding 40Hz audio, its potential efficacy is closely tied to the induction of gamma waves, associated with heightened focus and information processing. Laboratory studies suggest that playing 40Hz audio stimulates the brain to produce more gamma waves, hinting at its potential to enhance human cognitive function by regulating electrical brain activity. Binaural beat audio operates on a more intricate level. The brain attempts to "synchronize" two audio pieces with slightly different frequencies, generating a new EEG frequency. This neuroacoustic phenomenon induces specific brain activity, potentially enhancing cognitive function. Crucially, whether 40Hz audio or binaural beat audio, their efficacy may hinge on the "neuroplasticity" of the brain, signifying the brain's ability to alter its structure and function in response to sustained external stimulation. This "frequency-following response" induced by audio stimuli may bring about neuroplasticity changes, further enhancing cognitive function.

For specific brain disorders like Alzheimer's disease, audio therapy could prove impactful. In Alzheimer's patients, gamma-wave activity in the brain is typically diminished, but preliminary studies indicate that 40Hz audio stimulation may enhance gamma activity, potentially improving memory and attention. Moreover, binaural beat audio may contribute to enhancing mental and physical well-being. Research suggests that it can modify the brain's electrical activity pattern, improving emotional states, reducing anxiety and stress, and enhancing sleep quality.

In conclusion, both 40Hz audio and binaural beat audio, as potential non-pharmacological therapeutic strategies, warrant widespread attention from the research community. Although the current study is in its early stages, if audio therapy effectively ameliorates the cognitive dysfunction resulting from aneurysmal subarachnoid hemorrhage, it could introduce novel possibilities for the rehabilitation of this condition.

Being tested
Gamma Entrainment Stimulation
Medical subject headings
Subarachnoid Hemorrhage, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gamma Entrainment StimulationProcedure or surgery

    Also called Audio-assistied therapy

    Audio-assisted therapy: receive audio therapy with a specific device for 30 minutes, once in the morning and evening for 3 months.

    (Binaural beat treatment group: receive binaural beat treatment with a specific device for 30 minutes, once in the morning and evening, for 3 months.)

Study groups in NCT06346015
Study groupRoleWhat they receive
Gamma Entrainment Stimulation + Standard CareExperimentalGamma Entrainment Stimulation
Receives: Procedure: Gamma Entrainment Stimulation
Standard CareNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montreal Cognitive Assessment (MoCA) scores < 22

    Measured: at 3 months after enrollment

  2. mini-mental state examiniation (MMSE) < 27

    Measured: at 3 months after enrollment

  3. modified Rankin Scales (mRS) > 2

    unfavorable outcome

    Measured: at 3 months after enrollment

Secondary outcomes (2)
  1. electroencephalogram (EEG) indicators

    auditory steady state evoked response (ASSR) P(50), N(100) and P(200) components Frequency following responses (FFRs) EEG frequency ranges of alpha, beta, delta, theta and gamma

    Measured: at 3 months after enrollment

  2. functional Magnetic Resonance Imaging (fMRI) indicators

    ALFF: Amplitude of Low Frequency Fluctuation fALFF: fractional Amplitude of Low Frequency Fluctuation ReHo: Regional Homogeneity FC: Functional Connectivity VMHC: Voxel-Mirrored Homotopic Connectivity FCD: Functional Connectivity Density

    Measured: at 3 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2024
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06346015
Sponsor's protocol ID
HX-A-2023050
Acronym
GES-aSAH
Status last verified
Mar 2024
First submitted
18 Dec 2023
Last updated
3 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Iaccarino HF, Singer AC, Martorell AJ, Rudenko A, Gao F, Gillingham TZ, Mathys H, Seo J, Kritskiy O, Abdurrob F, Adaikkan C, Canter RG, Rueda R, Brown EN, Boyden ES, Tsai LH. Gamma frequency entrainment attenuates amyloid load and modifies microglia. Nature. 2016 Dec 7;540(7632):230-235. doi: 10.1038/nature20587.

    PubMed 27929004
  • Martorell AJ, Paulson AL, Suk HJ, Abdurrob F, Drummond GT, Guan W, Young JZ, Kim DN, Kritskiy O, Barker SJ, Mangena V, Prince SM, Brown EN, Chung K, Boyden ES, Singer AC, Tsai LH. Multi-sensory Gamma Stimulation Ameliorates Alzheimer's-Associated Pathology and Improves Cognition. Cell. 2019 Apr 4;177(2):256-271.e22. doi: 10.1016/j.cell.2019.02.014. Epub 2019 Mar 14.

    PubMed 30879788
  • Adaikkan C, Middleton SJ, Marco A, Pao PC, Mathys H, Kim DN, Gao F, Young JZ, Suk HJ, Boyden ES, McHugh TJ, Tsai LH. Gamma Entrainment Binds Higher-Order Brain Regions and Offers Neuroprotection. Neuron. 2019 Jun 5;102(5):929-943.e8. doi: 10.1016/j.neuron.2019.04.011. Epub 2019 May 7.

    PubMed 31076275
  • Chen X, Shi X, Wu Y, Zhou Z, Chen S, Han Y, Shan C. Gamma oscillations and application of 40-Hz audiovisual stimulation to improve brain function. Brain Behav. 2022 Dec;12(12):e2811. doi: 10.1002/brb3.2811. Epub 2022 Nov 14.

    PubMed 36374520

Questions about this trial

What is this clinical trial studying?

A study testing Gamma Entrainment Stimulation in people with Subarachnoid Hemorrhage, Aneurysmal and Cognitive Dysfunction, run by Beijing Tiantan Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fa Lin, MD (13681107240, 13681107240@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal Cognitive Assessment (MoCA) scores < 22 (time frame: at 3 months after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06346015, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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