Long-term Effect of θ Burst Magnetic Stimulation on Clinical Symptoms of Alzheimer Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- changes in Montreal Cognitive Assessment (MoCA)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
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.
Intervention: θ burst transcranial magnetic stimulation (Other)
Drug Group
Stable doses of cholinesterase inhibitors for the treatment and primary care guidance.Once every 3 months follow-up.
Intervention: Pharmacotherapy (Drug)
Outcomes
Primary Outcomes
changes in Montreal Cognitive Assessment (MoCA)
Time Frame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
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.
Secondary Outcomes
- The changes in MMSE(Mini Mental State Examination)(baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up)
- Verbal Fluency Test-letter and semantic (VFT-L/S).(baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up)
- LMT (Logic Memory Test)(baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up)
- TMT (Trail Making Test)(baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up)
- The Stroop color test(baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up)
- Boston Naming Test (BNT)(baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up)
- Symbol Digit Modalities Test (SDMT)(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)
- HVOT(Hooper visual organization test Hooper visual organization test)(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)
- DST (Digital Span Test; Forward and Backward)(baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up)
- JLOT(Judgment of line Judgment of line orientation test orientation test)(baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up)
- MRI measures(baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up)
- Chinese version of the Auditory Verbal Learning Test (AVLT)(baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up)
Investigators
WANG KAI
Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC
Anhui Medical University