CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
repetitive transcranial magnetic stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03977038
NCT03977038N/ACompleted

Investigation of Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on "Hot" and "Cold" Cognitive Systems In Treatment Resistant Depression (TRD)

Sunnybrook Health Sciences Centre·observational·Posted Jun 6, 2019·Updated Mar 15, 2023

In Brief

An observational study evaluating repetitive transcranial magnetic stimulation for Major Depressive Disorder and Treatment Resistant Depression. Completed, enrolled 25 participants across 1 site.

Detailed Summary

According to the World Health Organization, MDD is attributed as the leading cause of disability worldwide, leaving 300 million individuals affected. Despite the efficacy of pharmacotherapy, a subset of MDD patients, classified as TRD, exhibit suboptimal response and thus require alternative treatment options such as rTMS. Emotional-laden "hot"and Neutral "cold" cognitions are shown to be dysfunctional in depression. Potential pro-cognitive effects remain inconclusive. In this study the investigators seek to investigate whether visual scanning patterns of emotionally laden images may be a biological marker and predictor of rTMS antidepressant efficacy. If so, then changes in visual scanning patterns are expected to precede clinical symptom improvement. Furthermore, changes in visual scanning patterns (which characterizes the state of hot cognition) are compared simultaneously to changes in cold cognition in order to elucidate the neural mechanisms underlying rTMS-induced changes in cognition. It is hypothesized that participants who are responders to rTMS will exhibit a decrease in the amount of time spent looking at dysphoric images will precede clinically detectable changes in mood as measured by a reduction in the scores on the 17-item Hamilton Depression Rating Scale (HDRS-17). The hypothesis for this study corresponds to the alleviation of the dysfunction within the hot cognitive system as a result of rTMS and a potential compensatory effect of cold cognition as a natural reaction of resetting the allocation of cognitive resources.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 6, 2019
Enrollment StartMay 30, 2020
Primary CompletionJun 6, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.1 years ago

Interventions

repetitive transcranial magnetic stimulationdevice

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.