No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 60
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for people with depression who have had a spinal cord injury. Participants will receive a treatment called rTMS, which is designed to help improve mood without needing to move their hands.
Are You a Good Fit for This Trial?
You may be able to join if
I have had a spinal cord injury for at least 6 months.
I am between 18 and 60 years old.
I have been diagnosed with major depressive disorder.
My depression score is above 18.
I have not taken antidepressant medications for at least 4 weeks.
You may not be able to join if
I have another neurological disease or dementia.
I have a cognitive impairment.
I have a history of psychosis.
I have been diagnosed with bipolar disorder.
I have a history of claustrophobia.
I have a life expectancy of less than 1 year.
I have electronic or metallic implants in my body.
I have a history of seizures or take anti-seizure medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Depression is a leading cause of disability worldwide and is more commonly seen in individual's post-spinal cord injury (SCI) than in the general population. Depression post-SCI impacts an individuals' quality of life and recovery. It has been reported that among Veterans with an SCI, those without depression live longer than those with depression. Thus, depression must be treated appropriately. R…
Depression is a leading cause of disability worldwide and is more commonly seen in individual's post-spinal cord injury (SCI) than in the general population. Depression post-SCI impacts an individuals' quality of life and recovery. It has been reported that among Veterans with an SCI, those without depression live longer than those with depression. Thus, depression must be treated appropriately. Repetitive transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression, but dosing is based on a motor response or movement in the thumb. Over half of individuals with SCI have some degree of arm or hand impairment, so these individuals might not be eligible for rTMS, or they may receive the wrong dose. This study proposes clinical trial in individuals with depression post-SCI to assess the anti-depressant effect of a novel technique to dose rTMS that does not require a motor response in the thumb. By gaining a better understanding of the application of rTMS for depression post-SCI, the investigators aim to advance the rehabilitative care of Veterans.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* cervical or thoracic spinal cord injury at least 6 months prior with AIS A, B, C, or D;
* 18 - 60 years of age;
* major depressive disorder, as identified by Structured Clinical Interview for DSM-V;
* Hamilton Depression Rating Scale-17 score \> 18;
* not taking antidepressant…
Inclusion Criteria:
* cervical or thoracic spinal cord injury at least 6 months prior with AIS A, B, C, or D;
* 18 - 60 years of age;
* major depressive disorder, as identified by Structured Clinical Interview for DSM-V;
* Hamilton Depression Rating Scale-17 score \> 18;
* not taking antidepressant medications or no change in doses of psychotropic medication(s) for at least 4 weeks before the study (6 weeks if newly initiated medication)
Exclusion Criteria:
* concomitant neurologic diseases/disorders or dementia;
* cognitive impairment (Montreal Cognitive Assessment \<17);
* history of psychosis or other Axis I disorder that is primary;
* positive screen for bipolar disorder through the Mini-International Neuropsychiatric Interview;
* history of claustrophobia;
* life expectancy \<1 year;
* electronic or metallic implants (i.e., metal in the head, cochlear implant, or pacemaker;
* history of seizures or currently prescribed anti-seizure medications;
* taking medication that increases the risk of seizures;
* pregnancy as identified through a positive urine pregnancy test;
* Hamilton Depression Rating Scale-17 question #3 regarding suicide: \>2 or suicide attempt within the previous two years;
* inability to (University of California, San Diego Brief Assessment of Capacity to Consent) or declined to give informed consent.
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