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New treatment option for Spinal Cord Injuries
Official title Dosing rTMS for Depression Post-SCI
ClinicalTrials.gov ID: NCT05553353
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
You likely can't join if
- 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;
See the full eligibility 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.