TMS Stimulation and Cognitive Training in Alzheimer Patients
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|ClinicalTrials.gov Identifier: NCT01168245|
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : March 28, 2013
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|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 ]
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|Ages Eligible for Study:||55 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male or female age 55-85 years
- Patients diagnosed with early or moderate stage of Alzheimer's disease, according to the DSM-IV criteria.
- MMSE score 18 to 24
- Global Dementia rating 1 or 2
- Physically acceptable for the study as confirmed by medical history and exam, clinical laboratory results and EKG
- Spouse, family member or professional caregiver agree and capable of taking care and responsibility for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication)
- Written informed consent by both patient and legally responsible caregiver.
- Able to undergo MRI scan and EEG recordings prior to the onset of the study.
- Agreement to participate in up to 9 months the study.
- Right handed
- Hebrew or Russian as mother tongue and/or ability to read and understand the inform consent form (ICF), and the Patient Information document in Hebrew or Russian.
- Severe agitation;
- Mental retardation;
- Unstable medical condition;
- Use of benzodiazepines or other hypnotics during the study and preceding two weeks;
- Pharmacological immunosuppression;
- Participation in a clinical trial with any investigational agent within two weeks prior to study enrollment;
- History of Epileptic Seizures or Epilepsy;
- Contraindication for performing MRI scanning;
- Contraindication for receiving TMS treatment according to a TMS questionnaire;
- Clinically significant abnormal laboratory findings which have not been approved by the Principle Investigator;
- Patients treated with cholinesterase inhibitors, or memantine or ginko-biloba will be allowed to participate, if the treatment has started at least 2 months previous to recruited.
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|
|Responsible Party:||Neuronix Ltd|
|Other Study ID Numbers:||
|First Posted:||July 23, 2010 Key Record Dates|
|Last Update Posted:||March 28, 2013|
|Last Verified:||March 2013|
Central Nervous System Diseases
Nervous System Disease
Central Nervous System Diseases
Nervous System Diseases