NCT00753662

Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease

Phase 2 (Feasibility) Study of Transcranial Magnetic Stimulation as Additional Therapy to Drug Treatment in Patients With Alzheimer's Disease

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DEVICE	1Hz TMS with H2 coil	1Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
DEVICE	10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex	10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
DEVICE	SHAM TMS with H2 coil	SHAM TMS with H2 coil to prefrontal and parieto-temporal cortex

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2008-09-16
• Last updated: 2011-09-13

Locations

1 site across 1 country: Israel