TMS Stimulation and Cognitive Training in Alzheimer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01168245|
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : March 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Mild to Moderate||Device: Sham-NICE-System Device: NICE-System||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of a Combined TMS Stimulation and Cognitive Training in Alzheimer Patients: a Single-center, Randomized, Double-blind, Placebo-controlled Study|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Experimental: NICE-System NeuroAD
TMS combined with cognitive training
Sham Comparator: Sham-TMS
sham TMS and sham cognitive training
Other Name: NICE-System
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168245
|Assaf-Harofeh Medical Center|
|Beer Yaakov, Israel, 70300|
|Principal Investigator:||Martin Rabey, Prof.||Assaf-Harofeh Medical Center|