rTMS for Military TBI-related Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine
About this trial
The purpose of this study is to investigate the efficacy, safety, and tolerability of two dorsolateral prefrontal cortex (DLPFC) repetitive transcranial magnetic stimulation (rTMS) protocols to alleviate symptoms of depression in United States (U.S.) military service members and veterans with a history of concussion/mild traumatic brain injury (TBI).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-55 at the time of consent. Older individuals will not be enrolled in this initial trial for reasons of safety and expected reduced efficacy.
Current or former US military service member eligible for care at a Military Treatment Facility (MTF) or Veterans Administration Medical Center (VAMC.)
Able to provide written, informed consent in English .
Positive Loss of Consciousness of <30 minutes as confirmed by the TBI Screener and/or medical records and/or;
Disqualifiers
History of unprovoked seizures.
History of seizure within 24 hours of sustaining a concussion(s) or other head injury regardless of whether it was determined to have been related to concussion.
Family history of two or more unprovoked seizures in a first degree relative (parent, sibling, or child).
History of Moderate, Severe, or Penetrating TBI based on TBI Screener and/or medical records.
Trial design
Design model
Sequential
Treatments tested in this trial
Repetitive Transcranial Magnetic Stimulation (rTMS)
DeviceActive rTMS
Sham rTMS
DeviceSham comparator to active rTMS
Treatment groups
198 Participants
are divided into 3 treatment groupsGroup A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 1 intervention
Group C: Arm 3Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores
Change in Montgomery-Asberg Depression Rating Scale scores from baseline to post-intervention between groups. The Scale is designed to measure depression severity and consists of 10 items, each of which is scored on a Likert scale from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Time frame
Baseline to post-intervention, within 10 working days of the final rTMS session2
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores in a Subgroup
Change in Montgomery-Asberg Depression Rating Scale scores between groups from Baseline to post-intervention in participants who complete ≥80% of rTMS sessions. The Scale is designed to measure depression severity and consists of 10 items, each of which is scored on a Likert scale from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Time frame
Baseline to post-intervention, within 10 working days of the final rTMS session3
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores from Baseline to 6-month follow-up
Change in Montgomery-Asberg Depression Rating Scale scores from baseline to 6-month follow-up between groups. The Scale is designed to measure depression severity and consists of 10 items, each of which is scored on a Likert scale from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Time frame
Baseline to 6 months4
Comparison of Treatment Response or Remission in Montgomery-Asberg Depression Rating Scale (MADRS) Scores
Comparison of proportion of participants in each condition achieving treatment response ≥50% improvement in MADRS) or remission (MADRS ≤10)
Time frame
Baseline to post-intervention, within 10 working days of the final rTMS sessionSecondary outcomes
1
Comparison of Change in Inventory of Depressive Symptomatology-Self Report (IDS-SR) Scores from Baseline to post-intervention
Change in Inventory of Depressive Symptomatology-Self Report scores between groups. The Report is a 30-item self-report depressive symptom severity rating scale, with each question on a scale of 0 to 4; and a score range between 0 to 84, with a higher score reflecting higher symptom severity in depression.
Time frame
Baseline to post-intervention, within 10 working days of the final rTMS session2
Comparison of Change in Symptoms of Major Depressive Disorder Scale (SMDDS) Scores from Baseline to Post-intervention
Change in Symptoms of Major Depressive Disorder Scale scores between groups. The Scale is a 16-question scale, with each question using a rating scale between 0 ("Not at all" or "Never") to 4 ("Extremely" or "Always"); the total score ranges from 0 to 60 with a higher score indicating more severe depressive symptomatology.
Time frame
Baseline to post-intervention, within 10 working days of the final rTMS session3
Comparison of Change in Inventory of Depressive Symptomatology-Self Report (IDS-SR) Scores from Baseline to 6-month follow-up
Change in Inventory of Depressive Symptomatology-Self Report scores between groups. The Report is a 30-item self-report depressive symptom severity rating scale, with each question on a scale of 0 to 4; and a score range between 0 to 84, with a higher score reflecting higher symptom severity in depression
Time frame
Baseline to 6-month follow-up4
Comparison of Change in Symptoms of Major Depressive Disorder Scale (SMDDS) Scores from Baseline to 6-month follow-up
Change in Symptoms of Major Depressive Disorder Scale scores between groups. The Scale is a 16-question scale, with each question using a rating scale between 0 ("Not at all" or "Never") to 4 ("Extremely" or "Always"); the total score ranges from 0 to 60 with a higher score indicating more severe depressive symptomatology.
Time frame
Baseline to 6-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead sponsor
Uniformed Services University of the Health Sciences
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov