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TMS Stimulation and Cognitive Training in Alzheimer Patients

Primary Purpose

Alzheimer Disease, Mild to Moderate

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Sham-NICE-System
NICE-System
Sponsored by
Neuronix Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Disease, Cognitive Training, Cortical Reorganization, Brain Plasticity

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Assaf-Harofeh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

NICE-System NeuroAD

Sham-TMS

Arm Description

Treatment Group

Control Group

Outcomes

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.

Secondary Outcome Measures

Safety profile: rate of device and/or procedure related adverse events.

Full Information

First Posted
July 22, 2010
Last Updated
March 26, 2013
Sponsor
Neuronix Ltd
Collaborators
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01168245
Brief Title
TMS Stimulation and Cognitive Training in Alzheimer Patients
Official Title
Effects of a Combined TMS Stimulation and Cognitive Training in Alzheimer Patients: a Single-center, Randomized, Double-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuronix Ltd
Collaborators
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Mild to Moderate
Keywords
Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Disease, Cognitive Training, Cortical Reorganization, Brain Plasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NICE-System NeuroAD
Arm Type
Experimental
Arm Description
Treatment Group
Arm Title
Sham-TMS
Arm Type
Sham Comparator
Arm Description
Control Group
Intervention Type
Device
Intervention Name(s)
Sham-NICE-System
Other Intervention Name(s)
NICE-System
Intervention Description
sham TMS and sham cognitive training
Intervention Type
Device
Intervention Name(s)
NICE-System
Intervention Description
TMS combined with cognitive training
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Safety profile: rate of device and/or procedure related adverse events.
Time Frame
weekly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Rabey, Prof.
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf-Harofeh Medical Center
City
Beer Yaakov
ZIP/Postal Code
70300
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
23076723
Citation
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 (Vienna). 2013 May;120(5):813-9. doi: 10.1007/s00702-012-0902-z. Epub 2012 Oct 18.
Results Reference
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TMS Stimulation and Cognitive Training in Alzheimer Patients

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