Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as add-on Treatment for Early Alzheimer's Disease (ALSTIMAG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Neurology department of CHU Besancon (Dr Rumbach L, Dr Berger E, Dr Galmiche J)
Memory Center of Research and Resources (MCRR) of Besancon (Dr Magnin E)
Rapid-fr network (Dr Galmiche J)
Clinical Investigation Centre for Innovative Technology Network
Funding by French Internal Project Call for Clinical Research(2010-A00659-30)
Information provided by (Responsible Party):
Pr Pierre Vandel, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01481961
First received: November 23, 2011
Last updated: November 29, 2011
Last verified: November 2011
  Purpose

The aim of the investigators study 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). The rTMS is used in add-on drug treatment with IAChE administered for at least 3 months.

This study include 17 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.


Condition Intervention
Alzheimer's Disease
Cognition Disorders
Procedure: repetitive Transcranial Magnetic Stimulation (rTMS)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study: Cognitive Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)on add-on in Patients With Early Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • changes in MMSE (Mini Mental State Examination) [ Time Frame: baseline, 1wk, 4wk ] [ Designated as safety issue: No ]
    The changes in MMSE will constitute the major research outcome measure used to assess response to rTMS.


Secondary Outcome Measures:
  • changes in HDRS (Hamilton Depression Rating Scale) [ Time Frame: baseline, 1wk, 4wk ] [ Designated as safety issue: No ]
  • changes in STAI (State-Trait Anxiety Inventory) [ Time Frame: baseline, 1wk, 4wk ] [ Designated as safety issue: No ]
  • changes in BDI (Beck Depression Inventory) [ Time Frame: baseline, 1wk, 4 wk ] [ Designated as safety issue: No ]
  • changes in HAMA (Hamilton Anxiety Scale) [ Time Frame: baseline, 1 wk, 4 wk ] [ Designated as safety issue: No ]
  • changes in Mattis DRS (Dementia Rating Scale) [ Time Frame: baseline, 1 wk, 4 wk ] [ Designated as safety issue: No ]
  • changes in CDR (Clinical Dementia Rate) [ Time Frame: baseline, 1 wk, 4 wk ] [ Designated as safety issue: No ]
  • changes in Grober Free and Cued Selective Reminding Test [ Time Frame: baseline, 4 wk ] [ Designated as safety issue: No ]
  • changes in TMT (Trail Making Test) [ Time Frame: baseline, 4 wk ] [ Designated as safety issue: No ]
  • changes in COT (Crossing Of Test) [ Time Frame: baseline, 4 wk ] [ Designated as safety issue: No ]
  • changes in IST (Isaacs Set Test) [ Time Frame: baseline, 4 wk ] [ Designated as safety issue: No ]
  • changes in CDT (Clock-Drawing Test) [ Time Frame: baseline, 4 wk ] [ Designated as safety issue: No ]
  • changes in Signoret's Battery of Cognitive Efficacy (BEC96) [ Time Frame: baseline, 4 wk ] [ Designated as safety issue: No ]
  • changes in Rey-complex figure test-copy [ Time Frame: baseline, 4 wk ] [ Designated as safety issue: No ]
  • changes in Picture naming 80 items test (DO80) [ Time Frame: baseline, 4 wk ] [ Designated as safety issue: No ]
  • changes in RUD (Resource Utilisation Dementia) [ Time Frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk ] [ Designated as safety issue: No ]
  • changes in AI (Apathy Inventory) [ Time Frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk ] [ Designated as safety issue: No ]
  • changes in ADL (Activities of Daily Living) [ Time Frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk ] [ Designated as safety issue: No ]
  • changes in IADL (Instrumental Activities of Daily Living) [ Time Frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • changes in CP6 (Questionnaire of recent change in personnality) [ Time Frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk ] [ Designated as safety issue: No ]

Estimated Enrollment: 17
Study Start Date: November 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
  • subject under treatment by IAChE for at least 3 months.
  • CDR score ≤ 2
  • psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months

Exclusion Criteria:

  • CDR > 2
  • subjects diagnosed with psychiatric disorder (depression according to DSM-IV criteria, bipolar disorder, schizophrenia, addiction)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481961

Contacts
Contact: Pierre VANDEL, Prof +33381218073 pierre.vandel@univ-fcomte.fr
Contact: Magali NICOLIER, PhD +33381218073 mnicolier@chu-besancon.fr

Locations
France
Psychiatric Department of CHU of Besancon Recruiting
Besancon, France, 25000
Principal Investigator: Pierre VANDEL, Prof         
Sponsors and Collaborators
Pr Pierre Vandel
Neurology department of CHU Besancon (Dr Rumbach L, Dr Berger E, Dr Galmiche J)
Memory Center of Research and Resources (MCRR) of Besancon (Dr Magnin E)
Rapid-fr network (Dr Galmiche J)
Clinical Investigation Centre for Innovative Technology Network
Funding by French Internal Project Call for Clinical Research(2010-A00659-30)
Investigators
Principal Investigator: Pierre VANDEL, Prof Psychiatry clinical department - CHU Besançon
  More Information

Publications:
Responsible Party: Pr Pierre Vandel, PU PH, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01481961     History of Changes
Other Study ID Numbers: ALSTIMAG
Study First Received: November 23, 2011
Last Updated: November 29, 2011
Health Authority: France: Committee for the Protection of Personnes
France: Direction Générale de la Santé
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Besancon:
Alzheimer's disease
rTMS
cognition

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014