Clinical trial
Long-term Effect of θ Burst Magnetic Stimulation on Clinical Symptoms of Alzheimer Disease
Name
AHMU-AD-20210103
Description
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.
Trial arms
Trial start
2021-04-21
Estimated PCD
2022-05-17
Trial end
2022-12-31
Status
Completed
Treatment
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 .
Arms:
TBS Group
Pharmacotherapy
Stable doses of cholinesterase inhibitors were given and the patients were followed up every three months.
Arms:
Drug Group
Size
45
Primary endpoint
changes in Montreal Cognitive Assessment (MoCA)
baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ACTUAL'}}
Updated at
2023-02-28
1 organization
1 product
1 indication
Organization
Anhui Medical UniversityProduct
Pharmacotherapy