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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
rTMS real-sham
rTMS sham-real
Sponsored by
Dr. Zahra Kazem-Moussavi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's, rTMS, sleep quality, dementia, memory

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Misericordia Health Center
  • Riverview Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

rTMS with sham coil

rTMS with real coil

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cognitive Improvement Measured Using Montreal Cognitive Assessment (MoCA)
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

Improvement in Sleep Quality
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.

Full Information

First Posted
July 3, 2013
Last Updated
February 22, 2021
Sponsor
Dr. Zahra Kazem-Moussavi
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1. Study Identification

Unique Protocol Identification Number
NCT01894620
Brief Title
The Effect of rTMS Treatment on Alzheimer's and Sleep Quality
Acronym
rTMS
Official Title
Investigating the Effect of Repetitive Transcranial Magnetic Stimulation as a Treatment for Alzheimer's Disease and on Sleep Quality
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Zahra Kazem-Moussavi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's, rTMS, sleep quality, dementia, memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS with sham coil
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
rTMS with real coil
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
rTMS real-sham
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
rTMS sham-real
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive Improvement Measured Using Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
Change between baseline and 2 weeks after the start of treatment
Secondary Outcome Measure Information:
Title
Improvement in Sleep Quality
Description
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.
Time Frame
After four weeks after the start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zahra Kazem-Moussavi, Ph.D.
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Misericordia Health Center
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 1A2
Country
Canada
Facility Name
Riverview Health Center
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3L 2P4
Country
Canada

12. IPD Sharing Statement

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

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