TMS Stimulation and Cognitive Training in Alzheimer Patients

Neuronix

Status and phase

Completed

Phase 1

Conditions

Alzheimer Disease

Mild to Moderate

Treatments

Device: Sham-NICE-System

Device: NICE-System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01168245

NRX-NICE-PLA02

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

55 to 85 years old

Volunteers

No 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
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.