40Hz tACS in Treating Cognitive Function and Modulating Neurophysiology of Patients With Alzheimer's Disease
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable alzheimer-disease
Started Sep 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedNovember 13, 2023
November 1, 2023
1.9 years
January 25, 2023
November 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alzheimer's Disease Assessment Scale-Cognitive Subscale, ADAS-Cog
The ADAS-Cog consists of items from the following areas chosen for their sensitivity to Alzheimer's disease: language; memory; praxis; and orientation. The test takes 30-35 minutes to administer and the item scores generally range from 1-5.
Change from baseline, two weeks, and one months follow-up
Secondary Outcomes (9)
Wechsler adult intelligence scale, WAIS-IV, digit span
Change from baseline and two weeks
Wechsler adult intelligence scale, WAIS-IV, digit symbol coding
Change from baseline and two weeks
Wechsler adult intelligence scale, WAIS-IV, vocabulary
Change from baseline and two weeks
Subjective Cognitive Decline Questionnaire: SCD-QMyCog
Change from baseline and two weeks
Neuropsychiatric Inventory (NPI)
Change from baseline and two weeks
- +4 more secondary outcomes
Study Arms (2)
active tACS
ACTIVE COMPARATOR40 mins tACS for 10 consecutive daily sessions
sham tACS
SHAM COMPARATOR40 mins sham tACS for 10 consecutive daily sessions
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Che-Sheng Chulead
Study Sites (1)
Department of Psychiatry, Kaohsiung Veterans General Hospital
Kaohsiung City, 813, Taiwan
Related Publications (5)
Ching PY, Hsu TW, Chen GW, Pan CC, Chu CS, Chou PH. Efficacy and Tolerability of Cranial Electrotherapy Stimulation in the Treatment of Anxiety: A Systemic Review and Meta-Analysis. Front Psychiatry. 2022 Jun 9;13:899040. doi: 10.3389/fpsyt.2022.899040. eCollection 2022.
PMID: 35757229BACKGROUNDChou PH, Lin YF, Lu MK, Chang HA, Chu CS, Chang WH, Kishimoto T, Sack AT, Su KP. Personalization of Repetitive Transcranial Magnetic Stimulation for the Treatment of Major Depressive Disorder According to the Existing Psychiatric Comorbidity. Clin Psychopharmacol Neurosci. 2021 May 31;19(2):190-205. doi: 10.9758/cpn.2021.19.2.190.
PMID: 33888649BACKGROUNDChu CS, Li CT, Brunoni AR, Yang FC, Tseng PT, Tu YK, Stubbs B, Carvalho AF, Thompson T, Rajji TK, Yeh TC, Tsai CK, Chen TY, Li DJ, Hsu CW, Wu YC, Yu CL, Liang CS. Cognitive effects and acceptability of non-invasive brain stimulation on Alzheimer's disease and mild cognitive impairment: a component network meta-analysis. J Neurol Neurosurg Psychiatry. 2021 Feb;92(2):195-203. doi: 10.1136/jnnp-2020-323870. Epub 2020 Oct 28.
PMID: 33115936BACKGROUNDChen GW, Hsu TW, Ching PY, Pan CC, Chou PH, Chu CS. Efficacy and Tolerability of Repetitive Transcranial Magnetic Stimulation on Suicidal Ideation: A Systemic Review and Meta-Analysis. Front Psychiatry. 2022 May 6;13:884390. doi: 10.3389/fpsyt.2022.884390. eCollection 2022.
PMID: 35599760BACKGROUNDHung YY, Yang LH, Stubbs B, Li DJ, Tseng PT, Yeh TC, Chen TY, Liang CS, Chu CS. Efficacy and tolerability of deep transcranial magnetic stimulation for treatment-resistant depression: A systematic review and meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Apr 20;99:109850. doi: 10.1016/j.pnpbp.2019.109850. Epub 2019 Dec 19.
PMID: 31863873BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Che-Sheng Chu, MD
Department of Psychiatry, Kaohsiung Veterans General Hospital, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
January 25, 2023
First Posted
February 10, 2023
Study Start
September 1, 2023
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
November 13, 2023
Record last verified: 2023-11