TMS Stimulation and Cognitive Training in Alzheimer Patients

This study has been completed.
Sponsor:
Collaborator:
Assaf-Harofeh Medical Center
Information provided by (Responsible Party):
Neuronix Ltd
ClinicalTrials.gov Identifier:
NCT01168245
First received: July 22, 2010
Last updated: March 26, 2013
Last verified: March 2013

July 22, 2010
March 26, 2013
January 2010
September 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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, 4, 6, and 18 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01168245 on ClinicalTrials.gov Archive Site
Safety profile: rate of device and/or procedure related adverse events. [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alzheimer Disease
  • Mild to Moderate
  • Device: Sham-NICE-System
    sham TMS and sham cognitive training
    Other Name: NICE-System
  • Device: NICE-System
    TMS combined with cognitive training
    Other Name: NICE-System
  • Experimental: NICE-System NeuroAD
    Treatment Group
    Intervention: Device: NICE-System
  • Sham Comparator: Sham-TMS
    Control Group
    Intervention: Device: Sham-NICE-System
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 study. J Neural Transm. 2012 Oct 18. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01168245
NRX-NICE-PLA02
No
Neuronix Ltd
Neuronix Ltd
Assaf-Harofeh Medical Center
Principal Investigator: Martin Rabey, Prof. Assaf-Harofeh Medical Center
Neuronix Ltd
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP