Long-term Effect of θ Burst Magnetic Stimulation on Clinical Symptoms of Alzheimer Disease

Anhui Medical University

Status: Completed

Conditions: Repetitive Transcranial Magnetic Stimulation

Treatments: Drug: Pharmacotherapy; Other: θ burst transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04754152

AHMU-AD-20210103

Details and patient eligibility

About

This was a randomized, single-blind, parallel, placebo-controlled clinical trial assessing the efficacy of neuronavigational TBS among patients with AD. Fourty late-onset AD were included in the study, all the patients were divided into TBS groups and drug treatment group. Drug intervention group AD patients with drug regimen (donepezil 5mg / d) and primary care guidance, once every three months follow-up. TBS group is treated with TBS (a course of treatment every 3 months); after completing 4 treatments/follow-ups a year, evaluate the changes in MoCA, other clinical symptoms and multi-domain cognition tests, and brain Changes in structure and function.

Enrollment: 45 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
• Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia
• CDR score ≤ 2
• Subject under treatment by IAChE for at least 3 Weeks.
• psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months

Exclusion criteria

• CDR > 2

• Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).

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• History of head injury,stroke,or other neurologic disease.

• Organic brain defects on T1 or T2 images.

• History of seizures or unexplained loss of consciousness.

• Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.

• Family history of medication refractory epilepsy.

• History of substance abuse within the last 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

TBS Group

Experimental group

Description:

On the basis of drug treatment, a course of TBS treatment is performed every three months and 4 courses of treatment a year.

Treatment:

Other: θ burst transcranial magnetic stimulation

Drug Group

Placebo Comparator group

Description:

Stable doses of cholinesterase inhibitors for the treatment and primary care guidance.Once every 3 months follow-up.

Treatment:

Drug: Pharmacotherapy