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

NCT ID: NCT05723172

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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active tACS

40 mins tACS for 10 consecutive daily sessions

Group Type ACTIVE_COMPARATOR

active tACS

Intervention Type DEVICE

40 mins tACS for 10 consecutive daily sessions

sham tACS

40 mins sham tACS for 10 consecutive daily sessions

Group Type SHAM_COMPARATOR

sham tACS

Intervention Type DEVICE

40 mins sham tACS for 10 consecutive daily sessions

Interventions

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active tACS

40 mins tACS for 10 consecutive daily sessions

Intervention Type DEVICE

sham tACS

40 mins sham tACS for 10 consecutive daily sessions

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Che-Sheng Chu

OTHER

Sponsor Role lead

Responsible Party

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Che-Sheng Chu

Attending Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Che-Sheng Chu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Kaohsiung Veterans General Hospital, Taiwan

Locations

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Department of Psychiatry, Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Che-Sheng Chu

Role: CONTACT

07-3422121 ext. 72070

Facility Contacts

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Che-Sheng Chu, MD

Role: primary

+886-7-3422121 ext. 72068

References

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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.

Reference Type BACKGROUND
PMID: 35757229 (View on PubMed)

Chou 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.

Reference Type BACKGROUND
PMID: 33888649 (View on PubMed)

Chu 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.

Reference Type BACKGROUND
PMID: 33115936 (View on PubMed)

Chen 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.

Reference Type BACKGROUND
PMID: 35599760 (View on PubMed)

Hung 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.

Reference Type BACKGROUND
PMID: 31863873 (View on PubMed)

Other Identifiers

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VGHKS-112-01

Identifier Type: -

Identifier Source: org_study_id

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