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

February 27, 2015 updated by: Pierre Vandel, MD PhD

Feasibility Study: Cognitive Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)on add-on in Patients With Early Alzheimer's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • Psychiatric Department of CHU of Besancon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in MMSE (Mini Mental State Examination)
Time Frame: baseline, 1wk, 4wk
The changes in MMSE will constitute the major research outcome measure used to assess response to rTMS.
baseline, 1wk, 4wk

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in HDRS (Hamilton Depression Rating Scale)
Time Frame: baseline, 1wk, 4wk
baseline, 1wk, 4wk
changes in STAI (State-Trait Anxiety Inventory)
Time Frame: baseline, 1wk, 4wk
baseline, 1wk, 4wk
changes in BDI (Beck Depression Inventory)
Time Frame: baseline, 1wk, 4 wk
baseline, 1wk, 4 wk
changes in HAMA (Hamilton Anxiety Scale)
Time Frame: baseline, 1 wk, 4 wk
baseline, 1 wk, 4 wk
changes in Mattis DRS (Dementia Rating Scale)
Time Frame: baseline, 1 wk, 4 wk
baseline, 1 wk, 4 wk
changes in CDR (Clinical Dementia Rate)
Time Frame: baseline, 1 wk, 4 wk
baseline, 1 wk, 4 wk
changes in Grober Free and Cued Selective Reminding Test
Time Frame: baseline, 4 wk
baseline, 4 wk
changes in TMT (Trail Making Test)
Time Frame: baseline, 4 wk
baseline, 4 wk
changes in COT (Crossing Of Test)
Time Frame: baseline, 4 wk
baseline, 4 wk
changes in IST (Isaacs Set Test)
Time Frame: baseline, 4 wk
baseline, 4 wk
changes in CDT (Clock-Drawing Test)
Time Frame: baseline, 4 wk
baseline, 4 wk
changes in Signoret's Battery of Cognitive Efficacy (BEC96)
Time Frame: baseline, 4 wk
baseline, 4 wk
changes in Rey-complex figure test-copy
Time Frame: baseline, 4 wk
baseline, 4 wk
changes in Picture naming 80 items test (DO80)
Time Frame: baseline, 4 wk
baseline, 4 wk
changes in RUD (Resource Utilisation Dementia)
Time Frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
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
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
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
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
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
baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Vandel, MD PhD

Collaborators

Clinical Investigation Centre for Innovative Technology Network
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)
Funding by French Internal Project Call for Clinical Research(2010-A00659-30)

Investigators

  • Principal Investigator: Pierre VANDEL, Prof, Psychiatry clinical department - CHU Besançon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

November 23, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

November 30, 2011

Study Record Updates

Last Update Posted (Estimate)

March 3, 2015

Last Update Submitted That Met QC Criteria

February 27, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALSTIMAG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognition Disorders

Clinical Trials on repetitive Transcranial Magnetic Stimulation (rTMS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe