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

November 9, 2023 updated by: Che-Sheng Chu

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Recruiting
        • Department of Psychiatry, Kaohsiung Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: active tACS
40 mins tACS for 10 consecutive daily sessions
Device: active tACS
40 mins tACS for 10 consecutive daily sessions
Sham Comparator: sham tACS
40 mins sham tACS for 10 consecutive daily sessions
Device: sham tACS
40 mins sham tACS for 10 consecutive daily sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alzheimer's Disease Assessment Scale-Cognitive Subscale, ADAS-Cog
Time Frame: Change from baseline, two weeks, and one months follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wechsler adult intelligence scale, WAIS-IV, digit span
Time Frame: Change from baseline and two weeks
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
Wechsler adult intelligence scale, WAIS-IV, digit symbol coding
Time Frame: Change from baseline and two weeks
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
Wechsler adult intelligence scale, WAIS-IV, vocabulary
Time Frame: Change from baseline and two weeks
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
Subjective Cognitive Decline Questionnaire: SCD-QMyCog
Time Frame: Change from baseline and two weeks
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
Neuropsychiatric Inventory (NPI)
Time Frame: Change from baseline and two weeks
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
Mini-Mental State Examination, MMSE
Time Frame: Change from baseline and two weeks
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
HRV (heart rate variability)
Time Frame: Change from baseline, after one session, and two weeks
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
peripheral amyloid beta and tau related markers
Time Frame: Change from baseline and two weeks
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
EEG (electroencephalogram)
Time Frame: Change from baseline, after one session, and two weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Che-Sheng Chu

Investigators

  • Principal Investigator: Che-Sheng Chu, MD, Department of Psychiatry, Kaohsiung Veterans General Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS-112-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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