TMS Stimulation and Cognitive Training in Alzheimer Patients
|Alzheimer Disease Mild to Moderate||Device: Sham-NICE-System Device: NICE-System||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of a Combined TMS Stimulation and Cognitive Training in Alzheimer Patients: a Single-center, Randomized, Double-blind, Placebo-controlled Study|
- A significant improvement and/or improvement of at least 2 points on ADAS-COG of the Treatment Group in comparison with the Placebo Group after 6 weeks of treatment. [ Time Frame: pre-treatment, 6, and 18 weeks ]
- Safety profile: rate of device and/or procedure related adverse events. [ Time Frame: weekly ]
|Study Start Date:||January 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: NICE-System NeuroAD
TMS combined with cognitive training
Sham Comparator: Sham-TMS
sham TMS and sham cognitive training
Other Name: NICE-System
The current available pharmaceutical treatment for Alzheimer Disease (AD) is only partially and temporary effective. Therefore, new approaches are needed. rTMS is a non-invasive technique which generates a small electric current that induces a modulation in cortical excitability. In addition, cognitive training was suggested to improve cognitive functions in Alzheimer patients.
In this study we intend to treat mild to moderate AD patients with rTMS interlaced with cognitive training (rTMS- COG).
Patients with probable AD will be treated with rTMS-COG daily for 6 weeks followed by maintenance sessions for additional 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168245
|Assaf-Harofeh Medical Center|
|Beer Yaakov, Israel, 70300|
|Principal Investigator:||Martin Rabey, Prof.||Assaf-Harofeh Medical Center|