Transcranial Alternating Current Stimulation Combined With 40Hz Sound Stimulation for Treatment Alzheimer's Disease
1 other identifier
interventional
60
1 country
1
Brief Summary
Alzheimer's disease is characterized by progressive cognitive decline, and cognition is associated with cerebral concussion. Previous studies have found reduced gamma energy in the brain of AD patients. Therefore, modulation of gamma activity in AD patients may help improve cognitive function. The purpose of this study was to investigate the safety and tolerability of transcranial alternating current stimulation (tACS) combined with 40Hz sound stimulation in patients with mild to moderate Alzheimer's disease (AD); to compare the effects of tACS combined with sound stimulation, tACS, and 40Hz sound stimulation on cognition in AD patients; and the effects of tACS combined with sound stimulation, tACS, and 40Hz sound stimulation on brain network connectivity in AD patients before and after tACS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable alzheimer-disease
Started Dec 2021
Shorter than P25 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 23, 2021
CompletedFirst Submitted
Initial submission to the registry
January 19, 2022
CompletedFirst Posted
Study publicly available on registry
February 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedFebruary 23, 2022
February 1, 2022
1 year
January 19, 2022
February 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Alzheimer's Disease Assessment Scale cognitive subscale scores
ADAS-cog 11 scale ranges from 0 to 70, and higher value represents a worse outcome. This study will use ADAS-cog to assess changes in the global cognitive function after intervention.
up to 21 days (end of intervention) ,3 months
Secondary Outcomes (9)
Change in Montreal Cognitive Assessment scores
up to 21 days (end of intervention) ,3 months
Change in Mini-mental State Examination scores
up to 21 days (end of intervention) ,3 months
Change in Clinical Dementia Rating scores
up to 21 days (end of intervention) ,3 months
Change in Auditory Verbal Learning Test scores
up to 21 days (end of intervention) ,3 months
Change in Boston Naming Test scores
up to 21 days (end of intervention), 3 months
- +4 more secondary outcomes
Study Arms (3)
tACS combined with 40 Hz sound stimulation group
EXPERIMENTAL15 daily (Monday-Friday) 20min sessions of tACS combined with 40 Hz sound stimulation
tACS group
EXPERIMENTAL15 daily (Monday-Friday) 20min sessions of tACS stimulation
40 Hz sound stimulation group
EXPERIMENTAL15 daily (Monday-Friday) 20min sessions of 40 Hz sound stimulation
Interventions
The tACS instrument (model: XPNS208-B). Two electrodes are placed in the dorsolateral prefrontal cortex and the contralateral supraorbital area. and connected to the tACS device via a thin cable. The intervention will be performed using tACS (40 Hz, 1.5 mA) for 15 sessions of 20 min over 3 weeks (21 days). Sound stimulation apparatus: Two sponge earplugs were placed in the ears and the sound stimulator was set to (40Hz, 60dB). Sound stimulation was turned on simultaneously at the beginning of tACS. The duration of sound stimulation was set to 5 min stimulation, 5 min rest, 5 min stimulation, 1 min rest, and continued stimulation until the end of electrical stimulation while sound stimulation was turned off.
The tACS instrument (model: XPNS208-B). Two electrodes are placed in the dorsolateral prefrontal cortex and the contralateral supraorbital area. and connected to the tACS device via a thin cable. The intervention will be performed using tACS (40 Hz, 1.5 mA) for 15 sessions of 20 min over 3 weeks (21 days).
Sound stimulation apparatus: Two sponge earplugs were placed in the ears and the sound stimulator was set to (40Hz, 60dB). The duration of the sound stimulation was set to stimulate for 5 min, rest for 5 min, stimulate for 5 min, rest for 1 min, and last for a total of 20 min. 15 sessions of 20 min were performed over a period of 3 weeks (21 days).
Eligibility Criteria
You may qualify if:
- Age 40-80 years, male or female;
- Meet the diagnosis AD formulated by the National Institute on Aging and the Alzheimer's Association (NIA-AA) dementia diagnostic criteria;
- Clinical Dementia Rating Scale (CDR) =1.0 or 2.0;
- MMSE score ≤ 24;
- Able to move freely or with the aid of a walker or crutches;
- Good vision and hearing, able to cooperate with examination and treatment;
- Subjects voluntarily joined and had a guardian to sign the informed consent.
You may not qualify if:
- The presence of preoperative structural brain abnormalities (such as tumors, cerebral infarction, hydrocephalus or intracranial hemorrhage);
- The presence of other neurological disorders such as multiple sclerosis, epilepsy, Parkinson's disease, etc;
- Psychiatric system disorders: such as anxiety disorders, affective disorders such as depression, or pharmacogenic psychiatric disorders;
- Severe medical illness, current use of respiratory medications, cardiovascular medications, anticonvulsants or psychoactive drugs and clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine or cardiovascular disease, cancer, alcoholism or drug addiction;
- Severe hearing and visual impairment;
- Patients with clinical comorbidities with a life expectancy of less than 2 years;
- Patients who have undergone cranial surgery;
- Contraindications to undergoing magnetic resonance imaging or receiving transcranial alternating current stimulation (pacemakers, post DBS surgery);
- Eczema or sensitive skin;
- Familial Alzheimer's disease;
- Presence of other types of dementia: vascular dementia, Lewy body dementia, frontotemporal dementia, infectious dementia, etc;
- Other conditions that, in the opinion of the investigator, may not be suitable for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, 100853, China
Related Publications (2)
Liu Y, Liu S, Tang C, Tang K, Liu D, Chen M, Mao Z, Xia X. Transcranial alternating current stimulation combined with sound stimulation improves cognitive function in patients with Alzheimer's disease: Study protocol for a randomized controlled trial. Front Aging Neurosci. 2023 Jan 9;14:1068175. doi: 10.3389/fnagi.2022.1068175. eCollection 2022.
PMID: 36698862DERIVEDLiu Y, Tang C, Wei K, Liu D, Tang K, Chen M, Xia X, Mao Z. Transcranial alternating current stimulation combined with sound stimulation improves the cognitive function of patients with Alzheimer's disease: A case report and literature review. Front Neurol. 2022 Sep 23;13:962684. doi: 10.3389/fneur.2022.962684. eCollection 2022.
PMID: 36212652DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhiqi Mao, Ph.D
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 19, 2022
First Posted
February 23, 2022
Study Start
December 23, 2021
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
February 23, 2022
Record last verified: 2022-02