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

NCT ID: NCT04754152

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2022-12-31

Brief Summary

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.

Conditions

Repetitive Transcranial Magnetic Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TBS Group

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

Group Type: EXPERIMENTAL

θ burst transcranial magnetic stimulation

Intervention Type: OTHER

In addition to drug therapy, TBS supplementary therapy was given every 3 months.The TBS parameters were as follows: 3 pulses, 50 Hz bursts given every 200 ms (at 5 Hz), and an intensity of 70% of the resting motor threshold, as measured from the right first dorsal interosseous muscle using a handheld 70 mm figure-of-eight coil. Take a course every 10 weeks .

Drug Group

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

Group Type: PLACEBO_COMPARATOR

Pharmacotherapy

Intervention Type: DRUG

Stable doses of cholinesterase inhibitors were given and the patients were followed up every three months.

Interventions

θ burst transcranial magnetic stimulation

In addition to drug therapy, TBS supplementary therapy was given every 3 months.The TBS parameters were as follows: 3 pulses, 50 Hz bursts given every 200 ms (at 5 Hz), and an intensity of 70% of the resting motor threshold, as measured from the right first dorsal interosseous muscle using a handheld 70 mm figure-of-eight coil. Take a course every 10 weeks .

Intervention Type: OTHER

Pharmacotherapy

Stable doses of cholinesterase inhibitors were given and the patients were followed up every three months.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

WANG KAI

Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cognitive Neuropsychology Lab Anhui Medical University

Hefei, Anhui, China

Countries

China

References

Wu X, Yan Y, Hu P, Wang L, Wu Y, Wu P, Geng Z, Xiao G, Zhou S, Ji G, Qiu B, Wei L, Tian Y, Liu H, Wang K. Effects of a periodic intermittent theta burst stimulation in Alzheimer's disease. Gen Psychiatr. 2024 Jan 8;37(1):e101106. doi: 10.1136/gpsych-2023-101106. eCollection 2024.

Reference Type: DERIVED

PMID: 38274292 (View on PubMed)

Other Identifiers

AHMU-AD-20210103

Identifier Type: -

Identifier Source: org_study_id