Gamma Entrainment Stimulation for Cognitive Dysfunction After aSAH

NCT06346015 | Not Yet Recruiting

• 1 other identifier: HX-A-2023050
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Subarachnoid Hemorrhage, Aneurysmal; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (3)

• Montreal Cognitive Assessment (MoCA) scores < 22

  at 3 months after enrollment

• mini-mental state examiniation (MMSE) < 27

  at 3 months after enrollment

• modified Rankin Scales (mRS) > 2

  unfavorable outcome

  at 3 months after enrollment

Secondary Outcomes (2)

• electroencephalogram (EEG) indicators

  at 3 months after enrollment

• functional Magnetic Resonance Imaging (fMRI) indicators

  at 3 months after enrollment

Other Outcomes (1)

• Safety indicator

  at 3 months after enrollment

Study Arms (2)

Gamma Entrainment Stimulation + Standard Care

EXPERIMENTAL

Gamma Entrainment Stimulation

Procedure: Gamma Entrainment Stimulation

Standard Care

NO INTERVENTION

Interventions

Gamma Entrainment Stimulation PROCEDURE

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.）

Also known as: Audio-assistied therapy

Gamma Entrainment Stimulation + Standard Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Shanghai Joyingmed Sensory Stimulation Lab: collaborator

Related Publications (4)

• 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.

  PMID: 27929004 BACKGROUND

• 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.

  PMID: 30879788 BACKGROUND

• 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.

  PMID: 31076275 BACKGROUND

• 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.

  PMID: 36374520 BACKGROUND

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Guangzhi Shi, MD

  Beijing Tiantan Hospital

  STUDY DIRECTOR

• Jun Yang, MD

  Beijing Tiantan Hospital

  STUDY DIRECTOR

• Yu Chen, MD

  Beijing Tiantan Hospital

  STUDY DIRECTOR

• Ke Wang, MD

  Beijing Tiantan Hospital

  STUDY DIRECTOR

• Cunyang Li, MD

  Beijing Tiantan Hospital

  STUDY DIRECTOR

• Junwei Lv, MD

  Shanghai Joyingmed Sensory Stimulation Lab

  STUDY DIRECTOR

• Nianze Chen, MD

  Shanghai Joyingmed Sensory Stimulation Lab

  STUDY DIRECTOR

Central Study Contacts

Fa Lin, MD

CONTACT

13681107240; 13681107240@163.com

Runting Li, MD

CONTACT

tt18080lrt@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The relevant neuroimaging evaluation process is blinded to the evaluator to ensure the objectivity of the evaluation results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: April 3, 2024
• Study Start: April 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-03