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

NCT ID: NCT01481961

Last Updated: 2015-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-05-31

Brief 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.

Conditions

Alzheimer's Disease; Cognition Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rTMS arm

Group Type: EXPERIMENTAL

repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurology department of CHU Besancon (Dr Rumbach L, Dr Berger E, Dr Galmiche J)

UNKNOWN

Sponsor Role: collaborator

Memory Center of Research and Resources (MCRR) of Besancon (Dr Magnin E)

UNKNOWN

Sponsor Role: collaborator

Rapid-fr network (Dr Galmiche J)

UNKNOWN

Sponsor Role: collaborator

Clinical Investigation Centre for Innovative Technology Network

NETWORK

Sponsor Role: collaborator

Funding by French Internal Project Call for Clinical Research(2010-A00659-30)

UNKNOWN

Sponsor Role: collaborator

Pierre Vandel, MD PhD

OTHER

Sponsor Role: lead

Responsible Party

Pierre Vandel, MD PhD

PU PH

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pierre VANDEL, Prof

Role: PRINCIPAL_INVESTIGATOR

Psychiatry clinical department - CHU Besançon

Locations

Psychiatric Department of CHU of Besancon

Besançon, , France

Countries

France

References

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 disease. Brain Stimul. 2012 Jul;5(3):264-266. doi: 10.1016/j.brs.2011.03.003. Epub 2011 Mar 30. No abstract available.

Reference Type: RESULT

PMID: 22037125 (View on PubMed)

Other Identifiers

ALSTIMAG

Identifier Type: -

Identifier Source: org_study_id