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

NCT ID: NCT01894620

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-10-31

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

rTMS real-sham

Intervention Type: DEVICE

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.

rTMS sham-real

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

rTMS real-sham

Intervention Type: DEVICE

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.

rTMS sham-real

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Zahra Kazem-Moussavi

OTHER

Sponsor Role: lead

Responsible Party

Dr. Zahra Kazem-Moussavi

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zahra Kazem-Moussavi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Misericordia Health Center

Winnipeg, Manitoba, Canada

Riverview Health Center

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2012:76

Identifier Type: -

Identifier Source: org_study_id