TMS Stimulation and Cognitive Training in Alzheimer Patients
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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 |
- 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 ]
- 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 |
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| Israel | |
| Assaf-Harofeh Medical Center | |
| Beer Yaakov, Israel, 70300 | |
| 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 June 18, 2013