Back to results40Hz tACS in Treating Cognitive Function and Modulating Neurophysiology of Patients With Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
active tACS
sham tACS
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's disease, tACS
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
Sites / Locations
- Department of Psychiatry, Kaohsiung Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
active tACS
sham tACS
Arm Description
40 mins tACS for 10 consecutive daily sessions
40 mins sham tACS for 10 consecutive daily sessions
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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.
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).
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
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.
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.
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05723172
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Che-Sheng Chu
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's disease, tACS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active tACS
Arm Type
Active Comparator
Arm Description
40 mins tACS for 10 consecutive daily sessions
Arm Title
sham tACS
Arm Type
Sham Comparator
Arm Description
40 mins sham tACS for 10 consecutive daily sessions
Intervention Type
Device
Intervention Name(s)
active tACS
Intervention Description
40 mins tACS for 10 consecutive daily sessions
Intervention Type
Device
Intervention Name(s)
sham tACS
Intervention Description
40 mins sham tACS for 10 consecutive daily sessions
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cognitive Subscale, ADAS-Cog
Description
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.
Time Frame
Change from baseline, two weeks, and one months follow-up
Secondary Outcome Measure Information:
Title
Wechsler adult intelligence scale, WAIS-IV, digit span
Description
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.
Time Frame
Change from baseline and two weeks
Title
Wechsler adult intelligence scale, WAIS-IV, digit symbol coding
Description
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
Time Frame
Change from baseline and two weeks
Title
Wechsler adult intelligence scale, WAIS-IV, vocabulary
Description
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.
Time Frame
Change from baseline and two weeks
Title
Subjective Cognitive Decline Questionnaire: SCD-QMyCog
Description
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).
Time Frame
Change from baseline and two weeks
Title
Neuropsychiatric Inventory (NPI)
Description
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
Time Frame
Change from baseline and two weeks
Title
Mini-Mental State Examination, MMSE
Description
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.
Time Frame
Change from baseline and two weeks
Title
HRV (heart rate variability)
Description
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.
Time Frame
Change from baseline, after one session, and two weeks
Title
peripheral amyloid beta and tau related markers
Description
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
Time Frame
Change from baseline and two weeks
Title
EEG (electroencephalogram)
Description
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
Time Frame
Change from baseline, after one session, and two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Che-Sheng Chu
Phone
07-3422121
Ext
72070
Email
cschu@vghks.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Che-Sheng Chu, MD
Organizational Affiliation
Department of Psychiatry, Kaohsiung Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
35757229
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.
Results Reference
background
PubMed Identifier
33888649
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.
Results Reference
background
PubMed Identifier
33115936
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.
Results Reference
background
PubMed Identifier
35599760
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.
Results Reference
background
PubMed Identifier
31863873
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.
Results Reference
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40Hz tACS in Treating Cognitive Function and Modulating Neurophysiology of Patients With Alzheimer's Disease
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