NCT06565143

Effect of Transcranial Alternating Current Stimulation(tACS) for Early Alzheimer's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To investigate the clinical effect neural mechanism of transcranial alternating current stimulation in early Alzheimer's disease

Detailed description

Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and tACS at the First Affiliated Hospital of Anhui medical university. Patients were randomly allocated to tACS group and the sham group. There are about 20 patients in each group. For the all patients, allocation was by coin toss. Patients were studied using a double-blind design. Study participants and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only tACS administrators had access to the randomization list; they had minimal contact with the patients, and no role in cognitive and symptom assessments. Each patient would be treated for continuous 14 days by tACS. Before the tACS treatment, a series of cognitive assessments and neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) as the primary outcome measure and various other tasks and questionnaires to measure cognition (including MoCA,MMSE, DS, Stroop test, TMT, BNT-30, VFT, CDT,JLOT. Form H,HVOT), memory (CAVLT, LMT), emotion(HAMA-17,HAMD-14,GDS-30), behavioral and psychological symptoms(NPI), and treatment tolerability. All the tests are conducted in two days. The patient received resting EEG data collection. After the last treatment, the MoCA, and associative memory were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, resting EEG. Two months after the last treatment, participants were interviewed to obtain the same assessment as before. They were instructed to focus their answers on the past months.

Conditions

• Transcranial Alternating Current Stimulation
• Electroencephalography
• Early Alzheimer's Disease

Interventions

Type	Name	Description
DEVICE	Transcranial alternating current stimulation	Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation tool that alters cortical excitability and activity via application of weak alternating currents.
DEVICE	Sham transcranial alternating current stimulation	In the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (30s); no current was delivered during the 30-minute intervention.

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-03-01
• Completion: 2026-07-01
• First posted: 2024-08-21
• Last updated: 2024-08-21

Locations

1 site across 1 country: China