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. Identifier: NCT01168245
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : March 28, 2013
Assaf-Harofeh Medical Center
Information provided by (Responsible Party):
Neuronix Ltd

July 22, 2010
July 23, 2010
March 28, 2013
January 2010
September 2011   (Final data collection date for primary outcome measure)
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 ]
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, 4, 6, and 18 weeks ]
Complete list of historical versions of study NCT01168245 on Archive Site
Safety profile: rate of device and/or procedure related adverse events. [ Time Frame: weekly ]
Same as current
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TMS Stimulation and Cognitive Training in Alzheimer Patients
Effects of a Combined TMS Stimulation and Cognitive Training in Alzheimer Patients: a Single-center, Randomized, Double-blind, Placebo-controlled Study
The aim of this study is to examine if combined treatment with TMS and cognitive training (CoTra) for several weeks can produce a sustained improvement in cognitive and behavioral symptomatology of mild to moderate Alzheimer's disease (AD) patients.

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.

Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alzheimer Disease
  • Mild to Moderate
  • Device: Sham-NICE-System
    sham TMS and sham cognitive training
    Other Name: NICE-System
  • Device: NICE-System
    TMS combined with cognitive training
  • Experimental: NICE-System NeuroAD
    Treatment Group
    Intervention: Device: NICE-System
  • Sham Comparator: Sham-TMS
    Control Group
    Intervention: Device: Sham-NICE-System
Rabey JM, Dobronevsky E, Aichenbaum S, Gonen O, Marton RG, Khaigrekht M. Repetitive transcranial magnetic stimulation combined with cognitive training is a safe and effective modality for the treatment of Alzheimer's disease: a randomized, double-blind study. J Neural Transm (Vienna). 2013 May;120(5):813-9. doi: 10.1007/s00702-012-0902-z. Epub 2012 Oct 18.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Alcoholism;
  • 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.
Sexes Eligible for Study: All
55 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Neuronix Ltd
Neuronix Ltd
Assaf-Harofeh Medical Center
Principal Investigator: Martin Rabey, Prof. Assaf-Harofeh Medical Center
Neuronix Ltd
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP