The Effect of rTMS Treatment on Alzheimer's and Sleep Quality

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
Dr. Zahra Kazem-Moussavi, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01894620
First received: July 3, 2013
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

This research is being conducted to study whether rTMS (repetitive Transcranial Magnetic Stimulation) could be potentially used as a treatment for Alzheimer's disease. rTMS is a technique that stimulates the brain by rapidly switching a magnetic field in a coil placed over your head. Prior to rTMS, single pulse TMS will be used to localize the specific brain region that we are interested in.


Condition Intervention
Alzheimer's Disease
Device: rTMS real-sham
Device: rTMS sham-real

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Investigating the Effect of Repetitive Transcranial Magnetic Stimulation as a Treatment for Alzheimer's Disease and on Sleep Quality

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Cognitive improvement [ Time Frame: within 2 weeks after the start of treatment ] [ Designated as safety issue: No ]
    We anticipate to see a cognitive improvement after two weeks of applying rTMS


Secondary Outcome Measures:
  • Improvement in Sleep quality [ Time Frame: After four weeks after the start of treatment ] [ Designated as safety issue: No ]
    We anticipate to see an improvement on the sleep quality of the patients (assessed by EEG waves during sleep) after 4 weeks of rTMS treatment.


Estimated Enrollment: 20
Study Start Date: May 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: rTMS with sham coil
rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.
Device: rTMS real-sham
In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.
Device: rTMS sham-real
In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment.
Active Comparator: rTMS with real coil
rTMS real-sham and rTMS sham-real interventions. Each patient will receive both real and sham treatment in two different blocks of time. The assessments after the sham treatment will serve as placebo effect compared to those after real treatment.
Device: rTMS real-sham
In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.
Device: rTMS sham-real
In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment.

Detailed Description:

Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and rTMS treatments at the TMS Lab at Riverview Health Center. Each treatment session will involve implementing rTMS, while the patient is involved in a cognitive exercise such as naming object or action. The study sessions will be scheduled as follows: Block 1: 5 days/week for two weeks followed by 2 days a week for 1 week, followed by once a week for 1 week (total of 13 treatments); Pause: 4 weeks of no treatment; and Block 2: another 13 sessions of treatment with the same pattern as Block 1. One of these two sets of treatment (Block 1 or Block 2) will be sham and one will be real. Sham treatment sessions are identical to real treatment sessions, except that there is no magnetic stimulation. Patients will be randomly assigned to receive either sham or real treatment first. The purpose of sham treatment is to have a control group data that the plausible improvement as a result of rTMS can be compared to. By designing two sets of sham-real or real-sham treatment sessions, every participant will receive a real treatment, while we will also have control data.

The cognitive assessments will be done at the baseline, and then on weekly basis. A subgroup of the study population will be recruited for investigating the second objective: effect of rTMS on sleep quality. Those patients will be required to sign a second consent; then, the patients will go through full-night sleep study at Misericordia Health Center at the same time intervals as their cognitive assessments.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals must have a MoCA score between 5 and 26, indicating mild cognitive impairment or dementia.
  • Participants must have probable early or moderate Alzheimer's disease as confirmed by their treating neurologist or psychiatrist, and/or by the co-investigators.

Exclusion Criteria:

  • A recent (the last 3 months) history of stroke, recent (the last 3 months) head injury and loss of consciousness, any history of epilepsy, seizures, multiple sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS), or Autism.
  • Recent changes in medication (i.e. patients should be in a relatively stable phase of disease).
  • The presence of metallic objects in the body; dental implants are fine but people with pacemakers are to be excluded; basically anything that is unsafe under MRI would be considered unsafe for TMS application.
  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: NCT01894620

Contacts
Contact: Grant Rutherford, M.Sc. Umruthe4@cc.umanitoba.ca
Contact: Mari Garcia, B.Sc. umgarc36@cc.umanitoba.ca

Locations
Canada, Manitoba
Riverview Health Center Recruiting
Winnipeg, Manitoba, Canada, R3L 2P4
Contact: Zahra Moussavi, Ph.D.    204-478-6163    zahra.moussavi@umanitoba.ca   
Contact: Grant Rutherford, M.Sc.       Umruthe4@cc.umanitoba.ca   
Principal Investigator: Zahra Kazem-Moussavi, Ph.D.         
Sub-Investigator: lena Galimova, M.D.         
Misericordia Health Center Not yet recruiting
Winnipeg, Manitoba, Canada, R3C 1A2
Contact: Wayne Thompson, B.Sc.    204-788-8571    WThompson@exchange.hsc.mb.ca   
Principal Investigator: Eleni Giannouli, M.D.         
Sub-Investigator: Sonia Meza-Vargas, M.D.         
Sponsors and Collaborators
Dr. Zahra Kazem-Moussavi
Investigators
Principal Investigator: Zahra Kazem-Moussavi, Ph.D. University of Manitoba
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Zahra Kazem-Moussavi, Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01894620     History of Changes
Other Study ID Numbers: B2012:76
Study First Received: July 3, 2013
Last Updated: July 9, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Manitoba:
Alzheimer's
rTMS
sleep quality
dementia
memory

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 September 18, 2014