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
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Mild to Moderate
Device: Sham-NICE-System
Device: NICE-System
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Combined TMS Stimulation and Cognitive Training in Alzheimer Patients: a Single-center, Randomized, Double-blind, Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Neuronix Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Safety profile: rate of device and/or procedure related adverse events. [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: January 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NICE-System NeuroAD
Treatment Group
Device: NICE-System
TMS combined with cognitive training
Other Name: NICE-System
Sham Comparator: Sham-TMS
Control Group
Device: Sham-NICE-System
sham TMS and sham cognitive training
Other Name: NICE-System

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

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168245

Locations
Israel
Assaf-Harofeh Medical Center
Beer Yaakov, Israel, 70300
Sponsors and Collaborators
Neuronix Ltd
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Martin Rabey, Prof. Assaf-Harofeh Medical Center
  More Information

Publications:
Responsible Party: Neuronix Ltd
ClinicalTrials.gov Identifier: NCT01168245     History of Changes
Other Study ID Numbers: NRX-NICE-PLA02
Study First Received: July 22, 2010
Last Updated: March 26, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Neuronix Ltd:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Disease
Cognitive Training
Cortical Reorganization
Brain Plasticity

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014