Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease - Full Text View

Sponsors and Collaborators:	Tel-Aviv Sourasky Medical Center Brainsway
Information provided by:	Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT00753662

Purpose

The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H2 coil to prefrontal and parieto-temporal cortex to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.

Condition	Intervention	Phase
Alzheimer's Disease	Device: TMS with H2 coil	Phase II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 2 (Feasibility) Study of Transcranial Magnetic Stimulation as Additional Therapy to Drug Treatment in Patients With Alzheimer's Disease

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:

ADAS-COG [ Time Frame: Baseline, 2 months, 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

CGI-C, Neuropsychological computerized test NexSig [ Time Frame: Baseline, 2 months, 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 20 patients in group for TMS	Device: TMS with H2 coil TMS with H2 coil to prefrontal and parieto-temporal cortex
2: Placebo Comparator 20 patients in group for sham stimulation	Device: TMS with H2 coil Sham TMS with H2 coil to prefrontal and parieto-temporal cortex

Detailed Description:

Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C, Neuropsychological computerized test(time frame baseline, 2 months, 4 months.

Estimated enrollment: 40 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2009 Number of arms: 2

Interventions details: H2 coil device for Transcranial Magnetic Stimulation with MAGSTIM to prefrontal and parieto-temporal regions bilaterally with frequency 10 Herz in one arm and sham-stimulation with frequency 10 Herz in second arm.

Ages: 50-80 Genders: both

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent will be obtained
diagnostic evidence of probable AD consistent with DSM IV
stable treatment with Acetylcholine-Esterase Inhibitors or/and Memantine for 5 weeks prior to screening
stable dose treatment with other drugs
MMSE <25

Exclusion Criteria:

Patients with neurological or psychiatric disorders that affect cognition but are distinguishable from AD
Patients who are unwilling or unable to fulfill the requirements of the study
Severe personality disorder
Malignant or untreated Hypertension
History of Epilepsy
History of Head trauma
Metal implant in head, cardiac pacemaker, medical pump
Drug or alcohol addiction
Involvement in any other clinical trial during the preceding 3 month
Patient who are unwilling or unable to give Informed Consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753662

Contacts

Contact: Rachel Konopilski-Link

+972-3-6973698

rachell@tasmc.health.gov.il

Locations

Israel
Tel Aviv Sourasky Medical Center, Neurology Department
Tel Aviv, Israel, 64239

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Brainsway

Investigators

Principal Investigator:

Veronika Vakhapova, MD

Tel-Aviv Sourasky Medical Center

More Information

No publications provided

Responsible Party:	Tel Aviv Sourasky Medical Center ( Veronika Vakhapova, MD )
Study ID Numbers:	TMS in AD
Study First Received:	September 14, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00753662 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:

TMS AD H2 coil

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009