TMS Stimulation and Cognitive Training in Alzheimer Patients

Alzheimer Disease Clinical Trial

Official title:

Effects of a Combined TMS Stimulation and Cognitive Training in Alzheimer Patients: a Single-center, Randomized, Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01168245
• Other study ID #: NRX-NICE-PLA02
• Status: Completed
• Phase: Phase 1
• First received: July 22, 2010
• Last updated: March 26, 2013
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: March 2013
• Source: Neuronix Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Mild to Moderate

Intervention

Device:
• Sham-NICE-System
sham TMS and sham cognitive training
• NICE-System
TMS combined with cognitive training

Locations

Country	Name	City	State
Israel	Assaf-Harofeh Medical Center	Beer Yaakov

Sponsors (2)

Lead Sponsor	Collaborator
Neuronix Ltd	Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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 st — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		pre-treatment, 6, and 18 weeks	Yes
Secondary	Safety profile: rate of device and/or procedure related adverse events.		weekly	Yes