Ignite Creation Date:
2024-05-06 @ 1:45 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01894620
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2013-07-03
Brief Title:
The Effect of rTMS Treatment on Alzheimers and Sleep Quality
Sponsor:
Dr Zahra Kazem-Moussavi
Organization:
University of Manitoba
Study Overview
Official Title:
Investigating the Effect of Repetitive Transcranial Magnetic Stimulation as a Treatment for Alzheimers Disease and on Sleep Quality
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
rTMS
Brief Summary:
This research is being conducted to study whether rTMS repetitive Transcranial Magnetic Stimulation could be potentially used as a treatment for Alzheimers 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 daysweek 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None