Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease

Tel-Aviv Sourasky Medical Center45 enrolled

Overview

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.

Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C, Neuropsychological computerized test (Mindstream), FAB,ADL, Beck Depression Inventory-time frame baseline,1 month (visit 12) 2 months (visit 16), 4 months (visit 17). Estimated enrollment: 45 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2012 Number of arms: 3 Interventions details: H2 coil device for Transcranial Magnetic Stimulation with MAGSTIM to prefrontal and parieto-temporal regions bilaterally with frequency 10Hz in one arm, 1Hz in the second arm, and sham-stimulation with frequency 10Hz/1Hz in third arm. Ages: 50-80 Genders: both

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Alzheimer's Disease

Interventions

1Hz TMS with H2 coilDEVICE

1Hz TMS with H2 coil to prefrontal and parieto-temporal cortex

10Hz TMS with H2 coil to prefrontal and parieto-temporal cortexDEVICE

10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex

SHAM TMS with H2 coilDEVICE

SHAM TMS with H2 coil to prefrontal and parieto-temporal cortex

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Tel Aviv Sourasky Medical Center, Neurology Department

Tel Aviv, Israel

RECRUITING

Outcomes

Primary Outcomes

ADAS-COG

Time frame: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)

Secondary Outcomes

CGI-C, Neuropsychological computerized test (Mindstream),CGI-C,FAB,ADL, Beck Depression Inventory.

Time frame: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)

Central Contacts

Alissa Ash, Dr.

CONTACT

+972-3-6973698 elissaa@tasmc.health.gov.il

Data from ClinicalTrials.gov

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