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COMPLETEDPHASE1

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

NCT01168245•Neuronix Ltd

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

55 - 85 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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;
+2 more criteria

Locations (1)

Assaf-Harofeh Medical Center

Beer Yaakov, Israel

Key Dates

Start Date

January 1, 2010

Primary Completion Date

September 1, 2011

Completion Date

September 1, 2011

Last Updated

March 28, 2013

Enrollment

ACTUAL participants

Conditions

Alzheimer DiseaseMild to Moderate

Interventions

Sham-NICE-System

DEVICE

NICE-System

DEVICE

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Alzheimer DiseaseLymphatic Obstruction

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 28, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

TMS Stimulation and Cognitive Training in Alzheimer Patients

Inclusion Criteria

Exclusion Criteria

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