4Hz Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease

NCT04088643 | Unknown

• 1 other identifier: 2018077
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to explore the efficacy and safety of 4Hz transcranial alternating current stimulation (tACS) in patients with mild Alzheimer's disease (AD). The study will recruit 40 individuals with mild AD, and the participants will be randomized to either a 4 Hz tACS group or a sham stimulation group. Both groups will undergo 30 one-hour sessions across 3 weeks (21 days). At the end of the intervention and 3-month follow-up, all subjects will repeat the baseline assessments.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version)

  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)

Secondary Outcomes (15)

• Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version).

  3 months

• Change in brain volume and white matter integrity

  up to 21 days (end of intervention), 3 months

• Change in brain connectivity

  up to 21 days (end of intervention), 3 months

• Change in Mini-mental State Examination

  up to 21 days (end of intervention), 3 months

• Change in Montreal Cognitive Assessment

  up to 21 days (end of intervention), 3 months

Study Arms (2)

tACS group

EXPERIMENTAL

NEXALIN ADI transcranial alternating current stimulator

Device: transcranial alternating current stimulation

sham stimulation group

SHAM COMPARATOR

Sham stimulator provided by NEXALIN company

Device: sham stimulation

Interventions

transcranial alternating current stimulation DEVICE

The alternating current is administered through medical grade conductive pads that are produced specifically for the Nexalin technology. The pads are places on the forehead and behind each ear, and are connected to the Nexalin device with thin cables. Intervention will be implemented with a tACS device with 4Hz frequency and a peak-to-peak amplitude of 15mA, 30 one-hour sessions in 3 weeks (21 days).

tACS group

sham stimulation DEVICE

Electrodes will also be put on patient's forehead and behind each ear. The sham stimulator has the exactly same appearance with the true stimulator. Participants and operators cannot determine whether the stimulator is true based on its appearance or patients' feelings. However, when the device is started, no current flows through the electrodes. Participants in this controlled group will also receive sham stimulations with 30 one-hour sessions in 21 days.

sham stimulation group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with informed consent;
• years of age;
• At least 6 years of education;
• AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines;
• Clinical Dementia Rating Scale (CDR)=1.0;
• Positive findings in amyloid PET imaging or amyloid protein levels in CSF;
• On a stable dose of cholinesterase inhibitors (e.g. donepezil or rivastigmine) as defined as 6 consecutive weeks of treatment at an unchanging dose, and without any intentions to modify the dosage during the observation period.

You may not qualify if:

• Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke, progressive neurologic disease (e.g. multiple sclerosis), poorly controlled migraines or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment;
• Contraindication for undergoing MRI or receiving tACS;
• Eczema or sensitive skin;
• Familial AD;
• Depression or other psychiatric disorders;
• Abnormal brain structural magnetic resonance imaging (MRI) scan, including hydrocephalus, stroke, structural lesions, etc. that would potentially confound the outcome;
• Severe cardiovascular/pulmonary disorders;
• Other conditions, in the investigator's opinion, might not be suitable for the study.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Yi Tang, M.D., Ph.D.

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 13, 2019
• Study Start: October 14, 2019
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

CN (1)