Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01894620
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : February 12, 2018
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Zahra Kazem-Moussavi, University of Manitoba

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Device: rTMS real-sham Device: rTMS sham-real Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Investigating the Effect of Repetitive Transcranial Magnetic Stimulation as a Treatment for Alzheimer's Disease and on Sleep Quality
Study Start Date : May 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Cognitive Improvement Measured Using Montreal Cognitive Assessment (MoCA) [ Time Frame: Change between baseline and 2 weeks after the start of treatment ]
    We anticipate to see a cognitive improvement as measured by the Montreal Cognitive Assessment (MoCA) after two weeks of applying rTMS. This assessment tool gives a score from 0 to 30 points, with higher scores representing better cognitive ability.


Secondary Outcome Measures :
  1. Improvement in Sleep Quality [ Time Frame: After four weeks after the start of treatment ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894620


Locations
Layout table for location information
Canada, Manitoba
Misericordia Health Center
Winnipeg, Manitoba, Canada, R3C 1A2
Riverview Health Center
Winnipeg, Manitoba, Canada, R3L 2P4
Sponsors and Collaborators
Dr. Zahra Kazem-Moussavi
Investigators
Layout table for investigator information
Principal Investigator: Zahra Kazem-Moussavi, Ph.D. University of Manitoba
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dr. Zahra Kazem-Moussavi, Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01894620    
Other Study ID Numbers: B2012:76
First Posted: July 10, 2013    Key Record Dates
Results First Posted: February 12, 2018
Last Update Posted: February 24, 2021
Last Verified: February 2021
Keywords provided by Dr. Zahra Kazem-Moussavi, University of Manitoba:
Alzheimer's
rTMS
sleep quality
dementia
memory
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders