Clinical trial NCT05723172: 40Hz tACS in Treating Cognitive Function and Modulating Neurophysiology of Patients With Alzheimer's Disease
Official title: 40Hz tACS in Treating Cognitive Function and Modulating Neurophysiology of Patients With Alzheimer's Disease: a Triple Blind Randomized Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer's disease
tACS
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale, ADAS-Cog
timeFrame: Change from baseline, two weeks, and one months follow-up
Secondary outcomes:
measure: Wechsler adult intelligence scale, WAIS-IV, digit span
timeFrame: Change from baseline and two weeks
measure: Wechsler adult intelligence scale, WAIS-IV, digit symbol coding
timeFrame: Change from baseline and two weeks
measure: Wechsler adult intelligence scale, WAIS-IV, vocabulary
timeFrame: Change from baseline and two weeks
measure: Subjective Cognitive Decline Questionnaire: SCD-QMyCog
timeFrame: Change from baseline and two weeks
measure: Neuropsychiatric Inventory (NPI)
timeFrame: Change from baseline and two weeks
measure: Mini-Mental State Examination, MMSE
timeFrame: Change from baseline and two weeks
measure: HRV (heart rate variability)
timeFrame: Change from baseline, after one session, and two weeks
measure: peripheral amyloid beta and tau related markers
timeFrame: Change from baseline and two weeks
measure: EEG (electroencephalogram)
timeFrame: Change from baseline, after one session, and two weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Psychiatry, Kaohsiung Veterans General Hospital
Study officials:
affiliation: Department of Psychiatry, Kaohsiung Veterans General Hospital, Taiwan
name: Che-Sheng Chu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.