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

Alzheimer Disease Clinical Trial

Official title:

40Hz tACS in Treating Cognitive Function and Modulating Neurophysiology of Patients With Alzheimer's Disease: a Triple Blind Randomized Sham-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723172
• Other study ID #: VGHKS-112-01
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: November 2023
• Source: Kaohsiung Veterans General Hospital.
• Contact: Che-Sheng Chu
• Phone: 07-3422121
• Email: cschu[@]vghks.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• active tACS
40 mins tACS for 10 consecutive daily sessions
• sham tACS
40 mins sham tACS for 10 consecutive daily sessions

Locations

Country	Name	City	State
Taiwan	Department of Psychiatry, Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Che-Sheng Chu

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wechsler adult intelligence scale, WAIS-IV, digit span	The Wechsler Adult Intelligence Scale (WAIS) is an IQ test designed to measure intelligence and cognitive ability in adults and older adolescents. It is currently in its fourth edition (WAIS-IV) released in 2008 by Pearson, and is the most widely used IQ test, for both adults and older adolescents, in the world. We used WAIS-IV, digit span subscale, to examine attention among subjects; Digit span was by listening to sequences of numbers orally and to repeat them as heard, in reverse order, and in ascending order.	Change from baseline and two weeks
Secondary	Wechsler adult intelligence scale, WAIS-IV, digit symbol coding	We used WAIS-IV, digit symbol coding subscale, to examine processing speed among subjects; The digit symbol coding is a paper-and-pencil cognitive test presented on a single sheet of paper that requires a subject to match symbols to numbers according to a key located on the top of the page. The subject copies the symbol into spaces below a row of numbers. The number of correct symbols within the allowed time, usually 90 to 120 seconds, constitutes the score	Change from baseline and two weeks
Secondary	Wechsler adult intelligence scale, WAIS-IV, vocabulary	We used WAIS-IV, vocabulary subscale, to examine language function among subjects; The vocabulary subtest requires the client to try to define up to 30 words. This subtest assesses the client's understanding of words and reflects: language development, expressive language skills, cultural and educational experiences, ability to use words appropriately, retrieval of information from long-term memory.	Change from baseline and two weeks
Secondary	Subjective Cognitive Decline Questionnaire: SCD-QMyCog	The SCD-Q is a validated questionnaire that assesses the presence of a subjective cognitive decay in abilities such as memory, attention, language or executive functions. This scale is made up of two parts: MyCog is filled by the subject, TheirCog by the caregiver. Both parts have 24 identical dichotomous questions (yes/no), that evaluate decline for memory performances, language and executive functions in the last 2 years of daily life. The SCD-Q score for MyCog and TheirCog ranges from 0 to 24, with higher scores associated with greater perceived cognitive changes (cut to be classified as SCD = 7).	Change from baseline and two weeks
Secondary	Neuropsychiatric Inventory (NPI)	The Neuropsychiatric Inventory (NPI) was developed to assess dementia-related behavioral symptoms. The NPI examined 12 sub-domains of behavioral functioning: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, aberrant motor activity, night-time behavioral disturbances and appetite and eating abnormalities	Change from baseline and two weeks
Secondary	Mini-Mental State Examination, MMSE	A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory). The maximum score for the MMSE is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.	Change from baseline and two weeks
Secondary	HRV (heart rate variability)	Heart rate variability (HRV) is the physiological phenomenon of variation in the time interval between heartbeats. It is measured by the variation in the beat-to-beat interval. By measuring HRV, it reflects individual's sympathetic and parasympathetic tone.	Change from baseline, after one session, and two weeks
Secondary	peripheral amyloid beta and tau related markers	Peripheral Amyloid beta and tau protein as risk biomarkers of Alzheimer's disease. We check this to see the influence of tACS on AD-related biomarkers	Change from baseline and two weeks
Secondary	EEG (electroencephalogram)	An electroencephalogram (EEG) is a recording of brain activity. During this painless test, small sensors are attached to the scalp to pick up the electrical signals produced by the brain.; We will check time and/or frequency domain EEG characteristics between those receiving active and sham intervention at different time follow-up points	Change from baseline, after one session, and two weeks