An interventional study of repetitive Transcranial Magnetic Stimulation (rTMS) in Alzheimer's Disease and Cognition Disorders, sponsored by Pierre Vandel, MD PhD. Completed at 1 site in France. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-03-03.
Sponsored by Pierre Vandel, MD PhD · Not applicable, Interventional, and Treatment
The aim is to examine the effect of Repetitive Transcranial Magnetic Stimulation (rTMS) applied at the anodic left Cortex DorsoLateral PreFrontal (CDLPF) of patients with early Alzheimer's disease (AD).
This study included 15 patients treated with rTMS and whose medication reference is stabilized for 3 months by IAChE. Patients with early AD or related disease will be selected in the MCRR of Besançon and the psychiatric department of the University Hospital of Besançon. After giving informed consent, patients will be evaluated by a psychiatrist using the Mattis Clinical Demantia Rate (CDR), the Hamilton Depression Rating Scale (HDRS), State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI) and Hamilton Anxiety Scale (HAMA). The complete assessment takes 40 minutes. A second evaluation will be realized by a neuropsychologist takes around 120 minutes using Mattis CDR, Grober Free and Cued Selective Reminding Test, Trail Making Test (TMT), Crossing of Test (COT), Isaacs Set Test (STI) , Clock-Drawing Test (COT), Signoret's Battery of Cognitive Efficacy (BEC96), Rey-complex figure test-copy and Picture naming 80 items test (DO80).
Each rTMS session runs 20 minutes during which pulse trains of 5 seconds of 10 Hz spaced 25 seconds (2 trains of pulses per minute or 40 pulse trains per session) will be delivered. A psychometric assessment will be conducted again at the end of treatment week and one month after stopping treatment. A neuropsychometric assessment will be conducted one month after stopping the treatment. Scales of comfort and acceptability will also be proposed to the patient to determine whether any gene is caused by this treatment. Moreover a questionnaire will be proposed to the caregivers (at baseline, at the end of the treatment and 1, 2, 3 and 4 weeks after stopping the sessions) using Resource Utilisation Dementia (RUD), Apathy Inventory (AI), Activities of Daily Living (ADL) scale, Instrumental Activities of Daily Living (IADL) scale, Quality of Life in Alzheimer's disease (QoL-AD) scale, Questionnaire of recent change of the personality (CP6).
The population of this study will be comprised of patients between 60 to 85 years-old with early Alzheimer's characterized according to NINCDS-ADRADA criteria. These patients will be recruited on a voluntary basis, after notification and consent in the research center. This study was conducted over a period of 15 months.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 15 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
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Exclusion Criteria:
Procedure: repetitive Transcranial Magnetic Stimulation (rTMS)
After locating the left DLPFC, treatment with active rTMS will be directed by 20-minute session during which pulse trains of 5 seconds of 10 Hz spaced 25 seconds (2 trains of pulses per minute or 40 pulse trains per session). Treatment will occur 2 sessions per day during 5 days per week. Subjects will be monitored during rTMS for any side effects or adverse events.
changes in MMSE (Mini Mental State Examination)
The changes in MMSE will constitute the major research outcome measure used to assess response to rTMS.
Time frame: baseline, 1wk, 4wk
changes in HDRS (Hamilton Depression Rating Scale)
Time frame: baseline, 1wk, 4wk
changes in STAI (State-Trait Anxiety Inventory)
Time frame: baseline, 1wk, 4wk
changes in BDI (Beck Depression Inventory)
Time frame: baseline, 1wk, 4 wk
changes in HAMA (Hamilton Anxiety Scale)
Time frame: baseline, 1 wk, 4 wk
changes in Mattis DRS (Dementia Rating Scale)
Time frame: baseline, 1 wk, 4 wk
changes in CDR (Clinical Dementia Rate)
Time frame: baseline, 1 wk, 4 wk
changes in Grober Free and Cued Selective Reminding Test
Time frame: baseline, 4 wk
changes in TMT (Trail Making Test)
Time frame: baseline, 4 wk
changes in COT (Crossing Of Test)
Time frame: baseline, 4 wk
changes in IST (Isaacs Set Test)
Time frame: baseline, 4 wk
changes in CDT (Clock-Drawing Test)
Time frame: baseline, 4 wk
changes in Signoret's Battery of Cognitive Efficacy (BEC96)
Time frame: baseline, 4 wk
changes in Rey-complex figure test-copy
Time frame: baseline, 4 wk
changes in Picture naming 80 items test (DO80)
Time frame: baseline, 4 wk
changes in RUD (Resource Utilisation Dementia)
Time frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in AI (Apathy Inventory)
Time frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in ADL (Activities of Daily Living)
Time frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in IADL (Instrumental Activities of Daily Living)
Time frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in QoL-AD (Quality of Life in Alzheimer's Disease)
Time frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in CP6 (Questionnaire of recent change in personnality)
Time frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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