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Mild Cognitive ImpairmentNCT04135742

Effects of tACS Combined With CCT for Patients With MCI

A study testing Transcranial Alternating Current Stimulation and Cognitive Training in people with Mild Cognitive Impairment, run by Shanghai Mental Health Center at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This goal of this study is to explore the effects of transcranial alternating current stimulation(tACS) combined with computerized cognitive training(CCT) on improving cognition for patients with mild cognitive impairment(MCI). The study will recruit 195 patients with MCI. Read more about this study

Who is it for?
Ages 60 to 95 years
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Transcranial Alternating Current Stimulation and Cognitive Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
195 participants
Where
2 sitesChina
Study dates
11 Nov 2019to 30 Dec 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 60 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (1)age ≥ 60 years old with memory impairment; (2) the memory test scores are lower 1.5 SD than the normal control; (3) in addition to memory impairment, other cognitive functions remain relatively intact or only slightly impaired; (4) normal daily living ability; (5) can not reach the diagnostic criteria for dementia, Clinical Dementia Rating (CDR) is 0.5

Who cannot join

  • (1) serious medical diseases such as hypertension, heart disease, severe liver disease, etc.; (2) central nervous system diseases such as cerebrovascular diseases, infectious encephalopathy, brain tumors, etc.; (3) severe depression, schizophrenia and patients who have taken psychotropic substances for a long time; (4) Alzheimer's disease and vascular dementia; (5) history of alcohol dependence and other psychoactive substance abuse; (6) patients with contraindications for magnetic resonance imaging; (7) cannot complete the cognitive function tests for various conditions

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200030

  • Yangpu District Central Hospital

    Shanghai

Other trials in China

About this study

Official title: Effects of Transcranial Alternating Current Stimulation(tACS) Combined With Computerized Cognitive Training for Patients With Mild Cognitive Impairment(MCI)

This goal of this study is to explore the effects of transcranial alternating current stimulation(tACS) combined with computerized cognitive training(CCT) on improving cognition for patients with mild cognitive impairment(MCI). The study will recruit 195 patients with MCI. Participants will undergo baseline cognitve assessment, EEG and structural and functional MRI. Participants will be randomized to active tACS+CCT group, sham tACS+CCT group and active tACS+sham CCT group. At the end of the intervention, 3-month, 6-month and 12-month follow-up, all subjects will repeat the baseline assessments.

Read the detailed description

tACS is a non-invasive brain stimulation technique that uses a low-intensity alternating current (1 to 2 mA) to apply a sinusoidal current to the scalp, directly interacting with the oscillating cortical activity at a given frequency with a given stimulus intensity. Studies have shown that simultaneous tACS on the left prefrontal lobe and left temporal lobe can significantly improve working memory in healthy older adults. The 40 Hz tACS is gamma oscillation, and more and more studies have pointed out that gamma oscillation regulation disorder is associated with impaired working memory function.CCT can improve the cognition in patients with MCI. We hypothesized that tACS combined with CCT can produce synergistic effects in sensitive brain areas.

Being tested
Transcranial Alternating Current Stimulation, Cognitive Training
Keywords
Transcranial Alternating Current Stimulation, Computerized Cognitive Training
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Alternating Current StimulationDevice

    Transcranial alternate current stimulation (tACS) is a method of alternative current stimulation that can modulate neural activity by imposing local oscillatory activity.

  • Cognitive TrainingBehavioural

    Cognitive training includes memory, reasoning, processing speed and role playing, etc.

Study groups in NCT04135742
Study groupRoleWhat they receive
active tACS+ Cognitive Training groupExperimentalSubjects will receive CCT for a period of 3 months, 24 times, twice a week for 20 minutes each time. Placement of stimuli electrodes will be: a) active electrode over the left DLPFC (F3), and b) reference electrode over the right parietal region (P4). The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have 24 tACS sessions for three months, twice a week.The active tACS group will be stimulated with a 2 mA,40Hz current for 20 minutes each time during the stimulation.
Receives: Device: Transcranial Alternating Current Stimulation; Behavioral: Cognitive Training
sham tACS+Cognitive Training groupSham comparatorSubjects will receive CCT for a period of 3 months, 24 times, twice a week for 20 minutes each time. Placement of stimuli electrodes will be: a) active electrode over the left DLPFC (F3), and b) reference electrode over the right parietal region (P4). The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have 24 tACS sessions for three months, twice a week.The sham tACS group will have stimulation lasting only 40 seconds though the electrodes will remain in place for 20 min.
Receives: Behavioral: Cognitive Training
active tACS+ sham Cognitive Training groupSham comparatorSubjects will watch neutral pictures on iPad for a period of 3 months, 24 times, twice a week for 20 minutes each time. Placement of stimuli electrodes will be: a) active electrode over the left DLPFC (F3), and b) reference electrode over the right parietal region (P4). The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have 24 tACS sessions for three months, twice a week.The active tACS group will be stimulated with a 2 mA,40Hz current for 20 minutes each time during the stimulation.
Receives: Device: Transcranial Alternating Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline RBANS, Color Word Stroop Test (CWST),Visual Reasoning and Trails Making Task.

    Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS).CWST mainly can examine the executive function. Visual Reasoning will be assessed by the Cambridge Mental Disorders of the Elderly Examination Visual Reasoning Test.Executive function will be assessed by Trails Making Task.

    Measured: up to 3 months(end of the intervention)

  2. Neuroimage change from baseline Magnetic Resonance Imaging (MRI)

    Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI)

    Measured: up to 3 months(end of the intervention)

  3. changes in Gamma oscillation intensity (40-80 Hz) over DLPFC

    measured by electroencephalogram (EEG)

    Measured: up to 3 months(end of the intervention)

Secondary outcomes (8)

  1. Changes from baseline RBANS

    Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS).

    Measured: 3 months after the end of the intervention,6 months after the end of the intervention and 12 month after the end of the intervention

  2. Changes from baseline Color Word Stroop Test (CWST)

    CWST mainly can examine the executive function. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated.

    Measured: 3 months after the end of the intervention,6 months after the end of the intervention and 12 month after the end of the intervention

  3. Changes from baseline Visual Reasoning

    Visual Reasoning will be assessed by the Cambridge Mental Disorders of the Elderly Examination Visual Reasoning Test.

    Measured: 3 months after the end of the intervention,6 months after the end of the intervention and 12 month after the end of the intervention

  4. Changes from baseline Trails Making Task

    Executive function will be assessed by Trails Making Task.

    Measured: 3 months after the end of the intervention,6 months after the end of the intervention and 12 month after the end of the intervention

  5. Changes from baseline Geriatric Depression Scale (GDS)

    The Geriatric Depression Scale will be used to measure neuropsychiatric symptoms. It ranges from 0 to 30, and higher value represents a worse outcome.

    Measured: up to 3 months(end of the intervention),3 months after the end of the intervention,6 months after the end of the intervention and 12 month after the end of the intervention

  6. Changes from baseline in Geriatric Anxiety Inventory (GAI)

    Geriatric Anxiety Inventory (GAI) will be used to measure neuropsychiatric symptoms.

    Measured: up to 3 months(end of the intervention),3 months after the end of the intervention,6 months after the end of the intervention and 12 month after the end of the intervention

  7. Neuroimage changes from baseline Magnetic Resonance Imaging (MRI)

    Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI)

    Measured: 6 months after the end of the intervention and 12 month after the end of the intervention

  8. Side-effects of tACS

    Measured: At each stimulation session,up to 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start11 Nov 2019
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

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
195 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04135742
Sponsor's protocol ID
2019-24R
Status last verified
May 2022
First submitted
20 Oct 2019
Last updated
6 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Alternating Current Stimulation and Cognitive Training in people with Mild Cognitive Impairment, run by Shanghai Mental Health Center at 2 sites 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 1 inclusion and 1 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 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline RBANS, Color Word Stroop Test (CWST),Visual Reasoning and Trails Making Task. (time frame: up to 3 months(end of the intervention)). The study lists 3 primary outcomes in all. 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 NCT04135742.

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 6 May 2022.

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