Alzheimer DiseaseNCT05251649
Transcranial Alternating Current Stimulation Combined With 40Hz Sound Stimulation for Treatment Alzheimer's Disease
A study testing tACS combined with 40 Hz sound stimulation, Transcranial alternating current stimulation and 40 Hz sound stimulation in people with Alzheimer Disease, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- tACS combined with 40 Hz sound stimulation, Transcranial alternating current stimulation and 40 Hz sound stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2021to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, 100853
Zhiqi Mao, Ph.D, 8618910155994, markmaoqi@163.com
Zhiqi Mao, Ph.D
About this study
Official title: Transcranial Alternating Current Stimulation Combined With 40Hz Sound Stimulation for Treatment of Mild to Moderate Alzheimer's Disease
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.
Read the detailed description
The number of people with Alzheimer's disease is increasing every year, but the available drugs are not effective. Both transcranial alternating current stimulation (tACS) and sound stimulation are non-invasive methods to modulate Central Nervous System excitability. tACS has been shown to modulate cognitive processes by affecting intrinsic oscillatory manipulation and entrainment in the brain. And 40 Hz sound stimulation reduces Aβ amyloid deposition in the hippocampus of AD mice.
Sixty patients with mild-to-moderate AD will be recruited in this randomized, double-blind, controlled study. The researchers will evaluate whether tACS (40Hz) to the DLPFC region or 40Hz sound stimulation to both ears improves cognition in patients with mild to moderate AD. The study will also investigate which stimulation method has a more pronounced and sustained improvement in cognition in the following three groups of patients.
Subjects will be randomized into three groups, with the first group receiving tACS combined with sound stimulation, the second group receiving tACS alone, and the third group receiving sound stimulation alone. All will receive three weeks (15 sessions) of treatment. Patients will be assessed by neuropsychological testing at baseline, post-treatment (21 days) and at the 3-month follow-up. Subjects will be compared by functional MRI at baseline and post-treatment for brain network connectivity before and after treatment.
- Conditions
- Alzheimer Disease
- Being tested
- tACS combined with 40 Hz sound stimulation, Transcranial alternating current stimulation, 40 Hz sound stimulation
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACS combined with 40 Hz sound stimulationDevice
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.
Transcranial alternating current stimulationDevice
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).
40 Hz sound stimulationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| tACS combined with 40 Hz sound stimulation group | Experimental | 15 daily (Monday-Friday) 20min sessions of tACS combined with 40 Hz sound stimulation Receives: Device: tACS combined with 40 Hz sound stimulation |
| tACS group | Experimental | 15 daily (Monday-Friday) 20min sessions of tACS stimulation Receives: Device: Transcranial alternating current stimulation |
| 40 Hz sound stimulation group | Experimental | 15 daily (Monday-Friday) 20min sessions of 40 Hz sound stimulation Receives: Device: 40 Hz sound stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 21 days (end of intervention) ,3 months
Secondary outcomes (9)
Change in Montreal Cognitive Assessment scores
Montreal Cognitive Assessment (MoCA) will be used to evaluate the general cognitive function. MoCA ranges from 0 to 30, and higher value represents a better outcome.
Measured: up to 21 days (end of intervention) ,3 months
Change in Mini-mental State Examination scores
Mini-mental State Examination (MMSE) will be used to evaluate the general cognitive function. MMSE ranges from 0 to 30, and higher value represents a better outcome.
Measured: up to 21 days (end of intervention) ,3 months
Change in Clinical Dementia Rating scores
Clinical Dementia Rating(CDR) will be used to evaluate the level of dementia in AD patients. Mild dementia CDR: 1.0; Moderate dementia CDR: 2.0; Severe dementia CDR: 3.0.
Measured: up to 21 days (end of intervention) ,3 months
Change in Auditory Verbal Learning Test scores
auditory verbal learning test（AVLT）will be used to evaluate the memory function. AVLT ranges from 0 to 36, and higher values representing better outcome.
Measured: up to 21 days (end of intervention) ,3 months
Change in Boston Naming Test scores
Boston Naming Test（BNT-30） will be used to assess language function. It ranges from 0 to 30, and higher value represents a better outcome.
Measured: up to 21 days (end of intervention), 3 months
Change in Neuropsychiatric Inventory (NPI) scores
The Neuropsychiatric Inventory will be used to measure neuropsychiatric symptoms. It ranges from 0 to 144, and higher value represents a worse outcome.
Measured: up to 21 days (end of intervention), 3 months
Change in Activities of Daily Living scores
Activities of Daily Living (ADL) scale will be used to assess the change of life quality. It ranges from 20 to 80. The "20" represents normal life ability and the higher score presents the worse life ability.
Measured: up to 21 days (end of intervention), 3 months
Change in Magnetic Resonance Imaging performance
Function Magnetic Resonance Imaging (fMRI) will be used to measure changes in brain connectivity；Structural Magnetic Resonance Imaging (sMRI) will be used to measures structural changes in the brain.
Measured: up to 21 days (end of intervention), 3 months
Incidence of tACS Adverse events
Adverse Events as a result of tACS stimulation will be reported.
Measured: up to 21 days (end of intervention), 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start23 Dec 2021
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiqi Mao, Chinese PLA General Hospital
- Investigators
- Zhiqi Mao, Ph.D, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251649
- Sponsor's protocol ID
- ChinaPLAGH_LY
- Status last verified
- Feb 2022
- First submitted
- 19 Jan 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36698862Liu 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.
PubMed 36212652
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Alternating Current Stimulation Combined With 40Hz Sound Stimulation for Treatment of Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05251649
- Acronym / sponsor ID
- ChinaPLAGH_LY
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The number of people with Alzheimer's disease is increasing every year, but the available drugs are not effective. Both transcranial alternating current stimulation (tACS) and sound stimulation are non-invasive methods to modulate Central Nervous System excitability. tACS has been shown to modulate cognitive processes by affecting intrinsic oscillatory manipulation and entrainment in the brain. And 40 Hz sound stimulation reduces Aβ amyloid deposition in the hippocampus of AD mice.
Sixty patients with mild-to-moderate AD will be recruited in this randomized, double-blind, controlled study. The researchers will evaluate whether tACS (40Hz) to the DLPFC region or 40Hz sound stimulation to both ears improves cognition in patients with mild to moderate AD. The study will also investigate which stimulation method has a more pronounced and sustained improvement in cognition in the following three groups of patients.
Subjects will be randomized into three groups, with the first group receiving tACS combined with sound stimulation, the second group receiving tACS alone, and the third group receiving sound stimulation alone. All will receive three weeks (15 sessions) of treatment. Patients will be assessed by neuropsychological testing at baseline, post-treatment (21 days) and at the 3-month follow-up. Subjects will be compared by functional MRI at baseline and post-treatment for brain network connectivity before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tACS combined with 40 Hz sound stimulation group | Experimental | Device: tACS combined with 40 Hz sound stimulation15 daily (Monday-Friday) 20min sessions of tACS combined with 40 Hz sound stimulation |
| tACS group | Experimental | Device: Transcranial alternating current stimulation15 daily (Monday-Friday) 20min sessions of tACS stimulation |
| 40 Hz sound stimulation group | Experimental | Device: 40 Hz sound stimulation15 daily (Monday-Friday) 20min sessions of 40 Hz sound stimulation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tACS combined with 40 Hz sound stimulationThe 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. | Device | tACS combined with 40 Hz sound stimulation group |
| Transcranial alternating current stimulationThe 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). | Device | tACS group |
| 40 Hz sound stimulationSound 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). | Device | 40 Hz sound stimulation group |
Primary outcome
Change in Alzheimer's Disease Assessment Scale cognitive subscale scores
Time frame: up to 21 days (end of intervention) ,3 months
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.
9 secondary outcomes
Change in Montreal Cognitive Assessment scores
Time frame: up to 21 days (end of intervention) ,3 months
Change in Mini-mental State Examination scores
Time frame: up to 21 days (end of intervention) ,3 months
Change in Clinical Dementia Rating scores
Time frame: up to 21 days (end of intervention) ,3 months
Change in Auditory Verbal Learning Test scores
Time frame: up to 21 days (end of intervention) ,3 months
Change in Boston Naming Test scores
Time frame: up to 21 days (end of intervention), 3 months
Change in Neuropsychiatric Inventory (NPI) scores
Time frame: up to 21 days (end of intervention), 3 months
Change in Activities of Daily Living scores
Time frame: up to 21 days (end of intervention), 3 months
Change in Magnetic Resonance Imaging performance
Time frame: up to 21 days (end of intervention), 3 months
Incidence of tACS Adverse events
Time frame: up to 21 days (end of intervention), 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Derived from this study: PubMed 36698862Liu 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.
- Derived from this study: PubMed 36212652Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiqi Mao, Ph.D principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tACS combined with 40 Hz sound stimulation, Transcranial alternating current stimulation and 40 Hz sound stimulation in people with Alzheimer Disease, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiqi Mao, Ph.D (8618910155994, markmaoqi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alzheimer's Disease Assessment Scale cognitive subscale scores (time frame: up to 21 days (end of intervention) ,3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05251649, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.