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

NCT04754152 | Completed

• 1 other identifier: AHMU-AD-20210103
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• changes in Montreal Cognitive Assessment (MoCA)

  The changes in MoCA will constitute assess response to rTMS the secondary research outcome measure used to.MoCA was developed by Nasreddine et al. based on clinical experience and reference to the MMSE cognitive items and scores, and the final version was finalized in November 2004. We adopted a localized version (Mandarin version#includes 2 alternative versions) in line with the Chinese cultural background.It includes 11 inspection items in 8 cognitive fields, including visual structure skills, executive function, naming, attention and calculation, language, abstract thinking, memory, and orientation. With a total score of 30 or more than 26, it is normal. Anyone who has been education for less than 12 years will need to add one point to his final score. The final score of the higher the better, and we hope the subjects' scores will improve after treatment.

  baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up

Secondary Outcomes (16)

• The changes in MMSE(Mini Mental State Examination)

  baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up

• HAMD (Hamilton Depression Scale)

  baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up

• HAMA (Hamilton Anxiety Scale)

  baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up

• NPI (Neuropsychiatric Inventory)

  baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up

• ADL( Lawton-Brody Activities of Daily Living)

  baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up

Study Arms (2)

TBS Group

EXPERIMENTAL

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

Other: θ burst transcranial magnetic stimulation

Drug Group

PLACEBO COMPARATOR

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

Drug: Pharmacotherapy

Interventions

θ burst transcranial magnetic stimulation 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 .

TBS Group

Pharmacotherapy DRUG

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

Drug Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Cognitive Neuropsychology Lab Anhui Medical University

Hefei, Anhui, 230022, China

Location

Related Publications (1)

• 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.

  PMID: 38274292 DERIVED

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Study Record Dates

• First Submitted: January 30, 2021
• First Posted: February 15, 2021
• Study Start: April 21, 2021
• Primary Completion: May 17, 2022
• Study Completion: December 31, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)