fMRI-neuronavigated rTMS for the Treatment of Major Depression Associated With TBI

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder, Traumatic Brain Injury

In brief

This pilot study aims to investigate the efficacy of fMRI-targeted repetitive transcranial magnetic stimulation (rTMS) in treatment of major depression associated with traumatic brain injury (TBI). Half of patients will receive active treatment, while the other will receive a sham treatment with the option of receiving open-label active treatment afterwards.

Key facts

Study ID

NCT02980484

Run by

Washington University School of Medicine

People needed

15

Starts

2016-08-01

Expected to finish

2017-08-01

Last updated by the study team

2018-03-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults age 18 to 65
• History of traumatic brain injury (TBI) at least two weeks prior to study initiation
• Presence of an active major depressive episode as defined by DSM-5 criteria, including depression secondary to traumatic brain injury
• Baseline score of 10 or greater on Montgomery-Asberg Depression Rating Scale (MADRS)
• Failure of at least one prior antidepressant trial after the traumatic brain injury

You may not qualify if…

• History of:
• Moderate or severe substance use disorder in the past six months as defined by DSM-5 criteria, with the exception of cannabis and nicotine use disorders.
• Dementia, as defined by treating neurologist
• Moderate or severe autism spectrum disorder
• Bipolar disorder
• Schizophrenia spectrum disorders
• Current evidence of:
• Substance-induced mood disorder
• Active psychotic symptoms
• Depression secondary to a general medical illness, with the exception of TBI
• Dysphoria better explained by a baseline personality disorder than a major depressive episode
• Dysphoria better explained by a baseline anxiety disorder (including post-traumatic stress disorder) rather than a major depressive episode
• Active suicidal ideation
• Contraindications to rTMS treatment:
• Seizure disorder
• Significantly elevated seizure risk, as determined by clinician assessment
• TBI associated with elevated seizure risk, including penetrating injury and/or cortical intraparenchymal hemorrhage
• Presence of metallic objects within the head
• Presence of an implanted neurostimulation device within the head
• Contraindications to MRI
• Severe claustrophobia
• Severe pain/illness exacerbated by lying prone in the scanner
• Presence of non-MRI compatible metal foreign bodies or implants
• Weight in excess of 350 lbs
• Shoulder width in excess of maximum tolerable width for scanner

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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