Viewing Study NCT06346015



Ignite Creation Date: 2024-05-06 @ 8:20 PM
Last Modification Date: 2024-10-26 @ 3:25 PM
Study NCT ID: NCT06346015
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-04-03
First Post: 2023-12-18

Brief Title: Gamma Entrainment Stimulation for Cognitive Dysfunction After aSAH
Sponsor: Beijing Tiantan Hospital
Organization: Beijing Tiantan Hospital

Study Overview

Official Title: Efficacy of Gamma Entrainment Stimulation for Cognitive Dysfunction After Aneurysmal Subarachnoid Hemorrhage a Prospective Randomized Controlled Trial
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: GES-aSAH
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 brains 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 Alzheimers disease audio therapy could prove impactful In Alzheimers 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 brains 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None