Skip to content

Gamma Entrainment Stimulation for Cognitive Dysfunction After aSAH

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06346015
Acronym
GES-aSAH
Enrollment
60
Registered
2024-04-03
Start date
2024-04-01
Completion date
2025-03-31
Last updated
2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction, Subarachnoid Hemorrhage, Aneurysmal

Brief 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. 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.

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.

Interventions

PROCEDUREGamma Entrainment Stimulation

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.)

Sponsors

Shanghai Joyingmed Sensory Stimulation Lab
CollaboratorUNKNOWN
Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The relevant neuroimaging evaluation process is blinded to the evaluator to ensure the objectivity of the evaluation results.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Diagnosis of aneurysmal subarachnoid hemorrhage and aneurysm secured 2. Postoperative TAPS score ≥ 2 points 3. Age: 18 years old and 75 years old 4. Hearing function is not impaired and audio therapy is well tolerated 5. informed Consented

Exclusion criteria

1. Hearing impairment or significant discomfort with audio therapy 2. In other clinical trials within three months before the trial 3. Pregnant women and lactating women 4. Drugs that may affect cognitive function should be used during the study 5. Previous history including cognitive dysfunction or mental illness

Design outcomes

Primary

MeasureTime frameDescription
Montreal Cognitive Assessment (MoCA) scores < 22at 3 months after enrollment
mini-mental state examiniation (MMSE) < 27at 3 months after enrollment
modified Rankin Scales (mRS) > 2at 3 months after enrollmentunfavorable outcome

Secondary

MeasureTime frameDescription
electroencephalogram (EEG) indicatorsat 3 months after enrollmentauditory 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
functional Magnetic Resonance Imaging (fMRI) indicatorsat 3 months after enrollmentALFF: 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

Other

MeasureTime frameDescription
Safety indicatorat 3 months after enrollmentthe occurrence of serious adverse events. Including, but not limited to, serious physical or psychological reactions, serious complications or other health problems. All adverse events and serious adverse events will be recorded in detail, including the nature of the event, time to start and end, severity, association with study treatment, management measures, and outcome.

Contacts

Primary ContactFa Lin, MD
13681107240@163.com13681107240
Backup ContactRunting Li, MD
tt18080lrt@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026