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

Alzheimer's Disease Clinical Trial

— ALSTIMAG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481961
• Other study ID #: ALSTIMAG
• Status: Completed
• Phase: N/A
• First received: November 23, 2011
• Last updated: February 27, 2015
• Start date: November 2010
• Est. completion date: May 2012

Study information

• Verified date: February 2015
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Direction Générale de la SantéFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders

Intervention

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.

Locations

Country	Name	City	State
France	Psychiatric Department of CHU of Besancon	Besancon

Sponsors (6)

Lead Sponsor	Collaborator
Pierre Vandel, MD PhD	Clinical Investigation Centre for Innovative Technology Network, Funding by French Internal Project Call for Clinical Research(2010-A00659-30), Memory Center of Research and Resources (MCRR) of Besancon (Dr Magnin E), Neurology department of CHU Besancon (Dr Rumbach L, Dr Berger E, Dr Galmiche J), Rapid-fr network (Dr Galmiche J)

Country where clinical trial is conducted

France, 

References & Publications (1)

Haffen E, Chopard G, Pretalli JB, Magnin E, Nicolier M, Monnin J, Galmiche J, Rumbach L, Pazart L, Sechter D, Vandel P. A case report of daily left prefrontal repetitive transcranial magnetic stimulation (rTMS) as an adjunctive treatment for Alzheimer dis — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in MMSE (Mini Mental State Examination)	The changes in MMSE will constitute the major research outcome measure used to assess response to rTMS.	baseline, 1wk, 4wk	No
Secondary	changes in HDRS (Hamilton Depression Rating Scale)		baseline, 1wk, 4wk	No
Secondary	changes in STAI (State-Trait Anxiety Inventory)		baseline, 1wk, 4wk	No
Secondary	changes in BDI (Beck Depression Inventory)		baseline, 1wk, 4 wk	No
Secondary	changes in HAMA (Hamilton Anxiety Scale)		baseline, 1 wk, 4 wk	No
Secondary	changes in Mattis DRS (Dementia Rating Scale)		baseline, 1 wk, 4 wk	No
Secondary	changes in CDR (Clinical Dementia Rate)		baseline, 1 wk, 4 wk	No
Secondary	changes in Grober Free and Cued Selective Reminding Test		baseline, 4 wk	No
Secondary	changes in TMT (Trail Making Test)		baseline, 4 wk	No
Secondary	changes in COT (Crossing Of Test)		baseline, 4 wk	No
Secondary	changes in IST (Isaacs Set Test)		baseline, 4 wk	No
Secondary	changes in CDT (Clock-Drawing Test)		baseline, 4 wk	No
Secondary	changes in Signoret's Battery of Cognitive Efficacy (BEC96)		baseline, 4 wk	No
Secondary	changes in Rey-complex figure test-copy		baseline, 4 wk	No
Secondary	changes in Picture naming 80 items test (DO80)		baseline, 4 wk	No
Secondary	changes in RUD (Resource Utilisation Dementia)		baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk	No
Secondary	changes in AI (Apathy Inventory)		baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk	No
Secondary	changes in ADL (Activities of Daily Living)		baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk	No
Secondary	changes in IADL (Instrumental Activities of Daily Living)		baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk	No
Secondary	changes in QoL-AD (Quality of Life in Alzheimer's Disease)		baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk	No
Secondary	changes in CP6 (Questionnaire of recent change in personnality)		baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk	No