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Grant: Project Grant

Centre for Addiction and Mental Health (Toronto)

$818,550.00

A Randomized Sham-Controlled Trial of Accelerated Bilateral Theta Burst Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Late-Life Depression

FY 2022-23

Summary
Depression is the most common, treatable, mental disorder in late life, making it a major public health concern, with approximately 7% of the older adults suffering from late-life-depression (LLD). Repetitive transcranial magnetic stimulation (rTMS) is an evidence-based brain stimulation treatment for LLD. Theta burst stimulation (TBS) is a newer form of rTMS that can be delivered in only 4 min. The short session duration permits the delivery of multiple treatments per day, called accelerated TBS, instead of 30 daily treatments for 6 weeks. We propose a large sham-controlled trial to definitively evaluate accelerated bilateral TBS in late-life depression. This clinical trial will be conducted at two leading academic institutions in Canada: the Centre for Addiction and Mental Health (CAMH) and the Sunnybrook Hospital. 276 patients over 60 years old diagnosed with moderate or severe major depressive episode and lack of response to antidepressant treatment will be randomized to receive 8 treatment sessions per day of either active or sham accelerated TBS, for 5 consecutive days. Sham treatments will be delivered using a validated sham method. Participants will be followed for 4 weeks after the end of the treatment course. Our proposed study has the potential to have a significant impact on the treatment of LLD. Accelerated TBS could vastly increases the treatment capacity of rTMS clinics. One major obstacle for patients is the logistical issues associated with sessions 5 days per week for 30 days. For patients who live far from a clinic, scheduling 6 weeks of treatment is often an obstacle. Accelerated rTMS may enable patients to undergo treatment with less disruption of daily activities, and could also be an option for patients with a need for rapid treatment effects, such as patients in emergency or inpatient settings.
Program
Project Grant
Location
Ontario, Canada
Type
Grant
Source
CIHR Funding Decisions Database

As published

Id
470303
Name
Paulino Trevizol Alisson
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Neurosciences, Mental Health and Addiction
Theme2
Clinical
Prcname2
Randomized Controlled Trials 2
Projecttitle
A Randomized Sham-Controlled Trial of Accelerated Bilateral Theta Burst Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Late-Life Depression
Programtype2
Operating Grants
Orgnameinp2
Centre for Addiction and Mental Health (Toronto)
Cihramount2
$818,550
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Efficacy; Late-Life Depression; Major Depressive Disorder; Repetitive Transcranial Magnetic Stimulation; Theta Burst Stimulation
Abstract
Depression is the most common, treatable, mental disorder in late life, making it a major public health concern, with approximately 7% of the older adults suffering from late-life-depression (LLD). Repetitive transcranial magnetic stimulation (rTMS) is an evidence-based brain stimulation treatment for LLD. Theta burst stimulation (TBS) is a newer form of rTMS that can be delivered in only 4 min. The short session duration permits the delivery of multiple treatments per day, called accelerated TBS, instead of 30 daily treatments for 6 weeks. We propose a large sham-controlled trial to definitively evaluate accelerated bilateral TBS in late-life depression. This clinical trial will be conducted at two leading academic institutions in Canada: the Centre for Addiction and Mental Health (CAMH) and the Sunnybrook Hospital. 276 patients over 60 years old diagnosed with moderate or severe major depressive episode and lack of response to antidepressant treatment will be randomized to receive 8 treatment sessions per day of either active or sham accelerated TBS, for 5 consecutive days. Sham treatments will be delivered using a validated sham method. Participants will be followed for 4 weeks after the end of the treatment course. Our proposed study has the potential to have a significant impact on the treatment of LLD. Accelerated TBS could vastly increases the treatment capacity of rTMS clinics. One major obstacle for patients is the logistical issues associated with sessions 5 days per week for 30 days. For patients who live far from a clinic, scheduling 6 weeks of treatment is often an obstacle. Accelerated rTMS may enable patients to undergo treatment with less disruption of daily activities, and could also be an option for patients with a need for rapid treatment effects, such as patients in emergency or inpatient settings.
Competitiondate
202209
Approvedterm2
5 yrs 0 mth
Pinamesdelim
Paulino Trevizol, Alisson; Blumberger, Daniel M; Nestor, Sean M
Approvedterm
5 ans 0 mois
Cihrcontribution2
~ $818,550~ $0~
Centre for Addiction and Mental Health (Toronto) - $8… | Canada Spends