Investigation of the Effects of Repetitive Transcranial Magnetic Stimulation on Cognition in Depression
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|ClinicalTrials.gov Identifier: NCT03977038|
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : July 25, 2019
|Condition or disease||Intervention/treatment|
|Major Depressive Disorder Treatment Resistant Depression||Device: repetitive transcranial magnetic stimulation|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||40 participants|
|Target Follow-Up Duration:||1 Month|
|Official Title:||Investigation of Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on "Hot" and "Cold" Cognitive Systems In Treatment Resistant Depression (TRD)|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||May 2020|
Individuals in the treatment resistant depression (TRD) sample suffer from the condition called TRD. The intervention that will be administered to this group is the standardized rTMS treatment using High Frequency dTMS (HF-dTMS) stimulation over L-DLPFC, at the frequency of 18Hz, at 120% value of the individual's motor threshold, in 5 daily sessions per week, taking place each weekday, over the course of 6 weeks.
Device: repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS) is prescribed as first-line treatment for TRD patients (4). rTMS is safe, tolerable and non-invasive neurostimulation procedure where powerful magnetic pulses are transmitted through the skull into the underlying cortical cortex with the aim of electrical current induction within the neural tissue. This study administers a standard dose of rTMS treatment to the TRD patient sample consisting of high frequency deep TMS (HF-dTMS) stimulation over left dorsolateral prefrontal cortex (L-DLPFC), at the frequency of 18Hz, at 120% value of the individual's motor threshold, in 5 daily sessions per week, taking place each weekday, over the course of 6 weeks. The technology of dTMS, which will be used in this study, is an adaptation of the therapeutic intervention of rTMS with the advancement of possessing higher efficacy in targeting deeper brain regions of interest.
Healthy Controls (HC) sample
Individuals in the HC sample are age-, sex-, education-matched to the individuals in the TRD sample. HC sample does not receive any therapeutic treatment and are solely examined as a comparative measure of normal cognitive capabilities.
- Change in cold cognition [ Time Frame: Participants will be tested once every two weeks for six weeks. To follow up on investigating lasting results, this cognitive battery will be conducted at follow-up at one-month mark (Week 10) from the last visit at Week 6 ]Also known as neutral or "non-emotional" cognition, it will be measured by the Cambridge Neuropsychological Test Automated Battery (CANTAB) utilized in the domains of attention, executive function, memory and social/emotional cognition
- Change in hot cognition [ Time Frame: Participants will be tested once every two weeks for six weeks. To follow up on investigating lasting results, visual stimuli test will be conducted at one-month mark (Week 10) from the last visit at Week 6 ]Also known as "emotional" cognition, it will be measured through attentional imaging by an eye tracking task where participants will view image slides presenting images of different valences (emotional, neutral) and the participant's eye gaze estimates will be recorded
- depressive symptoms (physician-rated) [ Time Frame: TRD participants are assessed for their depressive symptom severity in response to rTMS treatment by the study psychiatrist every two weeks for six weeks, followed by a follow-up visit at one-month mark (Week 10). ]To assess depressive symptom severity in TRD participants, Hamilton Depression Rating Scale (HDRS-17) will be used. HDRS-17 is a 17-item scale, with some items ranging from a score of 0 to 2 points, and some 0 to 4 points. Higher scores represent worse outcome. Total score ranges include: 0-7 considered as "normal", 8-16 categorized as "mild depression", 17-23 as "moderate depression" and above 24 as "severe depression". Minimum score on the scale is 0 and the maximum score on the scale is 52.
- depressive symptoms (self-report) [ Time Frame: TRD participants are asked to self-report their depressive symptom severity in response to rTMS treatment every two weeks for six weeks, followed by a follow-up visit at one-month mark (Week 10). ]To assess depressive symptom severity in TRD participants, Quick Inventory of Depressive Symptomology (QIDS-SR16) will be used. QIDS-SR16 is a 16-item scale, with each item ranging from score of 0 to 3 points. Higher scores represent worse outcome. Total score ranges include: 0-5 considered as "no depression", 6-10 as "mild depression", 11-15 as "moderate depression", 16-20 categorized as "severe depression" and 21-27 as "very severe depression". Minimum score on the scale is 0 and the maximum score is 27.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977038
|Contact: Peter Giacobbe, MD, FRCPCemail@example.com|
|Contact: Dorsa Derakhshan, HBSc, MSc Candidatefirstname.lastname@example.org|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Dorsa Derakhshan, MSc Candidate email@example.com|
|Principal Investigator: Peter Giacobbe, MD, FRCPC|
|Principal Investigator:||Peter Giacobbe, MD, FRCPC||Harquail Centre For Neuromodulation, Sunnybrook Health Sciences Centre|