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NCT05723172 | Recruiting | Alzheimer Disease

40Hz tACS in Treating Cognitive Function and Modulating Neurophysiology of Patients With Alzheimer's Disease
Sponsor:

He-Sheng Chu

Information provided by (Responsible Party):

He-Sheng Chu

Brief Summary:

Gamma brain activity is crucial for cognitive function and intra-brain communication. Gamma frequency stimulation via transcranial alternating current stimulation(tACS) might alleviate memory deficits on both animal models of Alzheimer's disease (AD) and clinical trial. The study aims to assess the safety and efficacy of tACS on cognitive function and modulating neurophysiology in patients with AD.

Condition or disease

Alzheimer Disease

Intervention/treatment

active tACS

sham tACS

Phase

Not Applicable

Detailed Description:

Gamma brain activity is crucial for cognitive function and intra-brain communication. Gamma frequency stimulation via transcranial alternating current stimulation(tACS) might alleviate memory deficits on both animal models of Alzheimer's disease (AD) and clinical trial. The study aims to assess the safety and efficacy of tACS on cognitive function and modulating neurophysiology in patients with AD. 40mins 10Hz-tACS for daily consecutive sessions will be given.}}

Study Type : Interventional
Estimated Enrollment : 48 participants
Masking : Triple
Primary Purpose : Treatment
Official Title : 40Hz tACS in Treating Cognitive Function and Modulating Neurophysiology of Patients With Alzheimer's Disease: a Triple Blind Randomized Sham-controlled Trial
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : July 31, 2025
Arm Intervention/treatment

Active Comparator: active tACS

40 mins tACS for 10 consecutive daily sessions

Device: active tACS

Sham Comparator: sham tACS

40 mins sham tACS for 10 consecutive daily sessions

Device: sham tACS
Ages Eligible for Study: 60 Years to 90 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • aged 60- to 90-year-old
  • clinical dementia rating scale (CDR) of 1 or mini-mental state examination (MMSE) score of 18 to 26.
  • Participants were allowed to maintain their anti-dementia medications without changes from at 3 months before and throughout the study.
Exclusion Criteria
  • having contraindications for tACS, e.g., implanted brain medical devices or mental in the head, having arrhythmia and with pacemaker implantation, having history of seizures, having history of intracranial neoplasms or surgery, or severe head injuries or cerebrovascular diseases
  • clinical depression measured by Hamilton depression rating scale score equal and over 17
40Hz tACS in Treating Cognitive Function and Modulating Neurophysiology of Patients With Alzheimer's Disease

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40Hz tACS in Treating Cognitive Function and Modulating Neurophysiology of Patients With Alzheimer's Disease

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Locations

Recruiting

Taiwan,

Department of Psychiatry, Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 813