search
Back to results

Effects of Transcranial Magnetic Stimulation (TMS) and Cognitive Training for Alzheimer Patients

Primary Purpose

Alzheimer Disease, Early Onset

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
TMS stimulation
Sham comparator
Cognitive training
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease, Early Onset focused on measuring Alzheimer, TMS, cognitive training

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 15 to 26
  • 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 (transportation for the patient to and from the investigator's clinic, answering questions regarding the patient's condition and assuming responsibility for medication)
  • Written informed consent by patient or legally responsible caregiver.
  • Able to undergo MRI scanning sessions (e.g., prior to the onset of the study, upon the attainment of the primary end-point and at the end of the study).
  • Commitment to participation in six-to eighteen weeks of the trial regimen consisting of approximately1 hour TMS stimulation and cognitive training daily treatment of five days a week - six to eighteen weeks (and up to two treatments a day in case the Third TMS stimulation and cognitive training Treatment protocol if necessary).

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;
  • Clinically significant abnormal laboratory findings which have not been approved by the Project Director;

Sites / Locations

  • Assaf-Harofeh MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment Group (#1)

Control group (#2)

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of the efficacy of the TMS stimulation with cognitive training in treatment of early- to mid- stage Alzheimer's patients will be established by improvement of at least 4 points on ADAS-COG.

Secondary Outcome Measures

Safety will be established by paucity of related adverse events.

Full Information

First Posted
May 24, 2009
Last Updated
July 11, 2010
Sponsor
Assaf-Harofeh Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00909285
Brief Title
Effects of Transcranial Magnetic Stimulation (TMS) and Cognitive Training for Alzheimer Patients
Official Title
Testing the Effects of TMS Stimulation and Cognitive Training for Alzheimer Patients: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Current diagnosis of Alzheimer disease is made by clinical, neuropsychological, and neuroimaging assessments. Routine structural neuroimaging evaluation is based on nonspecific features, such as atrophy, which is a late feature in the progression of the disease. Therefore, developing new approaches for early and specific recognition of Alzheimer disease at the prodromal stages is of crucial importance. In the present study the investigators would like 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 Alzheimer's disease (AD) patients. A number of in vivo neuroimaging techniques, which can be used to reliably and noninvasively assess aspects of neuroanatomy, chemistry, physiology, and pathology, hold promise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Early Onset
Keywords
Alzheimer, TMS, cognitive training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group (#1)
Arm Type
Experimental
Arm Title
Control group (#2)
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
TMS stimulation
Intervention Description
TMS stimulation and cognitive training
Intervention Type
Device
Intervention Name(s)
Sham comparator
Intervention Description
Sham comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Intervention Description
TMS stimulation and cognitive training
Primary Outcome Measure Information:
Title
Evaluation of the efficacy of the TMS stimulation with cognitive training in treatment of early- to mid- stage Alzheimer's patients will be established by improvement of at least 4 points on ADAS-COG.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Safety will be established by paucity of related adverse events.
Time Frame
3 months

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 15 to 26 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 (transportation for the patient to and from the investigator's clinic, answering questions regarding the patient's condition and assuming responsibility for medication) Written informed consent by patient or legally responsible caregiver. Able to undergo MRI scanning sessions (e.g., prior to the onset of the study, upon the attainment of the primary end-point and at the end of the study). Commitment to participation in six-to eighteen weeks of the trial regimen consisting of approximately1 hour TMS stimulation and cognitive training daily treatment of five days a week - six to eighteen weeks (and up to two treatments a day in case the Third TMS stimulation and cognitive training Treatment protocol if necessary). 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; Clinically significant abnormal laboratory findings which have not been approved by the Project Director;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shai Efrati, MD
Organizational Affiliation
Assaf-Harofeh MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf-Harofeh MC
City
Beer-Yaakov
ZIP/Postal Code
70300
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Effects of Transcranial Magnetic Stimulation (TMS) and Cognitive Training for Alzheimer Patients

We'll reach out to this number within 24 hrs