rTMS real-sham
DeviceIn 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.
NCT Number: NCT01894620
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.
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Notify Me50 year–90 year
All sexes
Interventional
Not applicable
Misericordia Health Center, Winnipeg, Manitoba, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Dr. Zahra Kazem-Moussavi
Other
Investigating the Effect of Repetitive Transcranial Magnetic Stimulation as a Treatment for Alzheimer's Disease and on Sleep Quality
Acronym: rTMS
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