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Trial record 1 of 1 for:    NCT01168245
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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
Sponsor:
Collaborator:
Assaf-Harofeh Medical Center
Information provided by (Responsible Party):
Neuronix Ltd

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Mild to Moderate Device: Sham-NICE-System Device: NICE-System Phase 1

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NICE-System NeuroAD
Treatment Group
 Device: NICE-System
TMS combined with cognitive training
Sham Comparator: Sham-TMS
Control Group
 Device: Sham-NICE-System
sham TMS and sham cognitive training
Other Name: NICE-System


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Safety profile: rate of device and/or procedure related adverse events. [ Time Frame: weekly ]

Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Israel
Assaf-Harofeh Medical Center
Beer Yaakov, Israel, 70300
Sponsors and Collaborators
Neuronix Ltd
Assaf-Harofeh Medical Center
Investigators
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Principal Investigator: Martin Rabey, Prof. Assaf-Harofeh Medical Center
More Information
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Publications of Results:

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Responsible Party: Neuronix Ltd
ClinicalTrials.gov Identifier: NCT01168245    
Other Study ID Numbers: NRX-NICE-PLA02
First Posted: July 23, 2010    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013
Keywords provided by Neuronix Ltd:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Disease
Cognitive Training
Cortical Reorganization
Brain Plasticity
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders