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Effects of Transcranial Magnetic Stimulation (TMS) and Cognitive Training for 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: NCT00909285
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : July 13, 2010
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:

Current diagnosis of Alzheimer disease is made by clinical, neuropsychological, and neuroimaging assessments. Routine structural neuroimaging evaluation is based on nonspecific features, such as atrophy, which is a late feature in the progression of the disease. Therefore, developing new approaches for early and specific recognition of Alzheimer disease at the prodromal stages is of crucial importance.

In the present study the investigators would like 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 Alzheimer's disease (AD) patients. A number of in vivo neuroimaging techniques, which can be used to reliably and noninvasively assess aspects of neuroanatomy, chemistry, physiology, and pathology, hold promise.

Condition or disease Intervention/treatment Phase
Alzheimer Disease, Early Onset Device: TMS stimulation Device: Sham comparator Behavioral: Cognitive training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Testing the Effects of TMS Stimulation and Cognitive Training for Alzheimer Patients: A Pilot Study
Study Start Date : July 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment Group (#1) Device: TMS stimulation
TMS stimulation and cognitive training

Behavioral: Cognitive training
TMS stimulation and cognitive training

Sham Comparator: Control group (#2) Device: Sham comparator
Sham comparator

Primary Outcome Measures :
  1. Evaluation of the efficacy of the TMS stimulation with cognitive training in treatment of early- to mid- stage Alzheimer's patients will be established by improvement of at least 4 points on ADAS-COG. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Safety will be established by paucity of related adverse events. [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 15 to 26
  • 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 (transportation for the patient to and from the investigator's clinic, answering questions regarding the patient's condition and assuming responsibility for medication)
  • Written informed consent by patient or legally responsible caregiver.
  • Able to undergo MRI scanning sessions (e.g., prior to the onset of the study, upon the attainment of the primary end-point and at the end of the study).
  • Commitment to participation in six-to eighteen weeks of the trial regimen consisting of approximately1 hour TMS stimulation and cognitive training daily treatment of five days a week - six to eighteen weeks (and up to two treatments a day in case the Third TMS stimulation and cognitive training Treatment protocol if necessary).

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;
  • Clinically significant abnormal laboratory findings which have not been approved by the Project Director;

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 identifier (NCT number): NCT00909285

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Assaf-Harofeh MC
Beer-Yaakov, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
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Principal Investigator: Shai Efrati, MD Assaf-Harofeh MC
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Responsible Party: Dr. Shai Efrati, Assaf Harofeh Medical center Identifier: NCT00909285    
Other Study ID Numbers: NRX -NC-01
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: July 13, 2010
Last Verified: July 2010
Keywords provided by Assaf-Harofeh Medical Center:
cognitive training
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders