An interventional study of Theta Burst Stimulation ( Transcranial Magnetic Stimulation) in Depressive Disorder, Treatment-Resistant, sponsored by University of Calgary. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-10.
Sponsored by University of Calgary · Not applicable, Interventional, and Treatment
This study investigates the brain-based biomarkers of treatment response to accelerated theta burst stimulation (aTBS) in patients with Major Depressive Disorder resistant to pharmacological treatment(MDD) in an open label design.
Theta burst stimulation (TBS) is a newer form of rTMS which requires less stimulation time and produces longer lasting post-stimulation effects in the cerebral cortex (4). It has been shown to be effective in inducing synaptic plasticity and has similar or better efficacy in treating depression compared to rTMS (4).Newer accelerated TBS (aTBS) protocols that condense stimulation sessions down to several days rather than weeks have shown similar response rates when compared to prolonged TBS protocols, also with similar tolerability and safety. In order to develop aTBS as an effective treatment for MDD, future research should focus on identification of reliable predictors for better outcome to TBS. The main objectives were: 1) To directly compare multiple different brain-based measures (neuroimaging and electrophysiology) to identify which has the most power in accurately predicting response to TBS compared to sham. 2) To track both short and long-term longitudinal electrophysiological (EEG) changes related to the therapeutic effects of TBS.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The participant's depressive symptoms have previously demonstrated nonresponse to:
There is only one arm. All participants will receive Theta Burst Stimulation (transcranial magnetic stimulation) of the dorsolateral prefrontal cortex.
Device: Theta Burst Stimulation ( Transcranial Magnetic Stimulation)
Participants will receive bilateral TBS, 5 times daily (15 minutes between), over 5 consecutive days (25 sessions total). In each session they will receive intermittent TBS (iTBS) over left dorsolateral prefrontal cortex (DLPFC), followed by continuous TBS (cTBS) over right DLPFC. Stimulation sites will be targeted with the Localite neuronavigation system and Visor2 software, and according to Talairach coordinates in relation to individual MRIs. Intensity will be standardized at 120% of RMT. The MagPro stimulator will deliver iTBS over left DLPFC with 1620 pulses in 54 triplet bursts (5Hz) with train duration of 2 seconds, and intertrain interval of 8 seconds. cTBS over right DLPFC will consist of 1620 pulses in 54 triplet bursts, train duration of 2 seconds, with no intertrain interval.
Hamilton Depression Rating Scale
Clinician administered questionnaire to asses clinical improvement and classify response and remission
Time frame: Change from baseline at 5 days of TBS treatment
1. Montgomery-Åsberg Depression Rating Scale (MADRS)
A ten item clinician administered questionnaire to measure the severity of depressive symptoms on a 0 to 6 severity scale with higher scores indicating more severe depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Time frame: Change from baseline at 5 days of TBS treatment
2. Hamilton Anxiety rating Scale (HAM-A)
A rating scale to measure the severity of anxiety symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Time frame: Change from baseline at 5 days of TBS treatment
2. Columbia Suicide Severity Rating Scale ( CSSRS)
A suicidal rating scale devised by researchers at Columbia University. The presence of suicidal ideation score ranges from 1-5 and the intensity of the suicidal ideation ranges from 0-25 with higher scores indicating higher levels of intensity.
Time frame: Change from baseline at 5 days of TBS treatment
MGH Rumination questionnaire
Self administered 9 items scale to measure the severity of rumination. Each item is measured from 0-4 with a total score range of 0-36. Higher scores indicate more severe rumination.
Time frame: Change from baseline at 5 days of TBS treatment
Snaith-Hamilton Pleasure scale-Clinician administered (SHAP-C)
This is to evaluate the ability to enjoy/experience pleasure. Each item can score 0 or 1 with a total score possibility of 0-14. Higher scores represent higher anhedonia and 3 or over is considered abnormal.
Time frame: Change from baseline at 5 days of TBS treatment
36 item short form survey (SF-36)
This is to evaluate physical and emotional health.
Time frame: Change from baseline at 5 days of TBS treatment
Global Assessment of Functioning (GAF)
This is to evaluate psychological, social and occupational functioning
Time frame: Change from baseline at 5 days of TBS treatment
Resting state functional connectivity-Functional magnetic resonance imaging (rsfMRI)
Temporal correlation of brain signals as measured by BOLD signals
Time frame: Pretreatment baseline
Magnetic resonance spectroscopy (MRS)
To measure glutathione and glutamate concentration in DLPFC and ACC
Time frame: Pretreatment baseline
Electroencephalogram
To measure neuronal oscillations
Time frame: Change from baseline at 5 days of TBS treatment
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Calgary