Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease

Phase 2

• Conditions: Alzheimer's Disease
• Interventions: Device: 1Hz TMS with H2 coil; Device: 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex; Device: SHAM TMS with H2 coil

• Registration Number: NCT00753662
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2008-09-14
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-16
• Study Start: 2008-11
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-12
• Last Update Posted: 2011-09-13
• Primary Completion: 2012-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	1Hz TMS with H2 coil	15 patients in group 1 will be treated with 1Hz frequency
2	10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex	15 patients in group 2 will be treated with 1Hz frequency 10Hz
3	SHAM TMS with H2 coil	15 patients in group 3 will be treated with SHAM (1Hz/10Hz)

Primary Outcome Measures

Name	Time	Method
ADAS-COG	Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)

Secondary Outcome Measures

Name	Time	Method
CGI-C, Neuropsychological computerized test (Mindstream),CGI-C,FAB,ADL, Beck Depression Inventory.	Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center, Neurology Department; 🇮🇱 Tel Aviv, Israel