Compressed Intermittent Theta Burst Stimulation (ciTBS)
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|ClinicalTrials.gov Identifier: NCT04684706|
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : December 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Treatment Resistant Depression||Device: intermittent Theta Burst Stimulation||Not Applicable|
Major depressive disorder (MDD) is a disabling mental disorder with a lifetime prevalence of up to16% . Approximately 30% of MDD patients suffer treatment resistant depression (TRD), with at least 2 failed adequate trials of pharmacotherapy. Repetitive transcranial magnetic stimulation (rTMS) has been shown to be a safe treatment for TRD, yet the standard clinical technique for using it as treatment depressive disorders is associated with limited efficacy to date. Among the potential causes of limited efficacy have been the scalp based targeting technique that is currently the most common targeting method rather than techniques that incorporate functional magnetic resonance imaging (fMRI) neuronavigation, which have been shown to have greater efficacy. Image guided TMS can target specific functional brain networks with greater resolution that takes into account individual differences in brain anatomy.
Another technique for improving treatment efficacy, shown to modulate cortical excitability, may be the application of intermittent theta-burst stimulation in regular intervals, which has been shown to be no different than a longer-in-time application of rTMS. Paired with the evidence that iTBS has produced significant antidepressant responses in severely depressed individuals, and that relapse in depressive states predicts diminished efficacy of treatment as well as increased quantity of TBS pulses to have a beneficial effect, these recent iTBS findings suggest that iTBS may offer a valid treatment alternative to options that have proven otherwise ineffective in treating TRD. Therefore, the investigators aim to administer iTBS to severely-depressed participant in a shorter amount of time, in order to improve their antidepressant outcome.
Significance: This protocol builds on different notions:
- iTBS is not different in treatment outcome than rTMS while applying the same amount of pulses in shorter amount of time;
- The degree of treatment resistance is indicative of iTBS quantity needed to obtain an antidepressant treatment
- Repeated iTBS produces a significant effect in treating refractory depression
- Decreasing the interval between iTBS applications enhanced positive treatment outcomes.
Therefore, the compression of iTBS pulses with shorter intervals between sessions is hypothesized to have an increased beneficial effect on individuals affected by treatment-resistant depression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Within Study on the Effects of L-dlPFC Activation Through iTBS in Refractory Depression|
|Actual Study Start Date :||February 20, 2020|
|Estimated Primary Completion Date :||February 19, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Compressed iTBS schedule
Stimulation 3-pulse 50-Hz bursts at 5-Hz for 2-s trains, with trains every 10 s, for 10 minutes, 10 times a day, for 5 consecutive days.
Device: intermittent Theta Burst Stimulation
The present study will utilize TMS dosage of iTBS of 18 000 pulses a day for 5 consecutive days.
- Depressive Symptoms Change [ Time Frame: 2 Weeks ]Depressive symptoms will be measured before and after treatment by means of the clinician-administered Montgomery Asberg Depression Rating Scale (MADRS) (0-60, lower scores indicate lower depressive symptoms) and the self report Beck Depression Inventory (BDI II) (0-30, lower scores indicate lower depressive symptoms). Change will be measured by comparing measurements pre- and post- on the same measures. The bigger the change, the bigger the reduction in depressive symptoms.
- Self report Symptom Change [ Time Frame: 2 weeks ]Depressive symptoms will be measured before and after treatment by means of the self report Beck Depression Inventory (BDI II) (0-30, lower scores indicate lower depressive symptoms). Change will be measured by comparing measurements pre- and post- on the same measures. The bigger the change, the bigger the reduction in depressive symptoms.
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): NCT04684706
|Contact: Tommaso Girelli||267 560 email@example.com|
|Contact: Janet Stockfirstname.lastname@example.org|
|United States, Pennsylvania|
|Center for Neuromodulation in Depression and Stress||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Maria Prociuk 215-573-4229 email@example.com|
|Principal Investigator: Yvette Sheline, MD|
|Principal Investigator:||Yvette Sheline, MD||Perelman School of Medicine University of Pennsylvania|