Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as add-on Treatment for Early Alzheimer's Disease
Condition: Alzheimer's Disease; Cognition Disorders
MeSH terms: Alzheimer Disease; Cognition Disorders
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention type(s): Procedure
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's disease; rTMS; cognition