Treatment of Depression Post-SCI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rTMS.
- Who it may be relevant to
- Registry conditions: Depression, Spinal Cord Injuries. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment of Depression Post-SCI: Retrospective Analysis and Feasibility Trial
Overview
Depression is more common after a spinal cord injury (SCI) than in the general population. Unfortunately, it is unknown how depression is typically treated in individuals with SCI or if commonly used treatment methods are effective. This study will investigate the safety and impact of a novel method for treating depression called repetitive transcranial magnetic stimulation (rTMS). rTMS is a type of non-invasive brain stimulation. Fourteen individuals with a cervical or thoracic level SCI and depression will complete an approved treatment plan using rTMS. Participants will be treated using rTMS five days a week for four weeks. After four weeks of treatment, the study team will review the safety of rTMS and assess changes in depressive symptoms. If the results are positive, larger studies can be designed to develop better treatment options for individuals with SCI and depression.
Interventions
- Device rTMS
The study team will deliver rTMS five days a week for four weeks, according to a specific and approved protocol for participant positioning, motor threshold determination, and dosing.
Primary outcome measures
- Safety as assessed by number of adverse events [Time frame: Through the study period (5 weeks)]
- Number of visits missed [Time frame: Throughout the treatment period (4 weeks)]
- Change in depressive symptoms as assessed by the Hamilton Rating Scale for Depression [Time frame: Baseline, midpoint (Week 3), and post treatment (5 weeks)]
Secondary outcome measures (7)
- Change in depressive symptoms as assessed by the Montgomery- Asberg Depression Rating Scale (MADRS) [Time frame: Baseline, midpoint (Week 3), and post treatment (5 weeks)]
- Change in the impact depressive symptoms have on one's life as assessed by the Sheehan Disability Scale. [Time frame: Baseline, midpoint (Week 3), and post treatment (5 weeks)]
- Change in subjective well-being based on the Satisfaction With Life Scale. [Time frame: Baseline and post treatment (5 weeks)]
- Change in physical activity based on the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury [Time frame: Baseline and post treatment (5 weeks)]
- Change in function as assessed by the Spinal Cord Independence Measure III-Self Report. [Time frame: Baseline and post treatment (5 weeks)]
- Change in function and daily activities as assessed by the Craig Handicap Assessment and Reporting Tool-Short Form [Time frame: Baseline and post treatment (5 weeks)]
- Change depressive symptoms as assessed by the Patient Health Questionnaire-9 score [Time frame: Baseline, midpoint (Week 3), and post treatment (5 weeks)]
Eligibility criteria
Inclusion criteria
- Age 18 - 70;
- At least 6 months post incomplete cervical or incomplete or complete thoracic level SCI;
- Have at least partial active movement of the right thumb (abductor pollicis brevis) to allow for FDA approved rTMS dosing;
- Major depressive disorder, as identified through screening tools;
- No antidepressant medications or no change in doses of psychotropic medication(s) for at least 4 weeks prior to the study (6 weeks if newly initiated medication).
Exclusion criteria
- Concomitant neurologic diseases/disorders or dementia;
- Cognitive impairment, as identified through a screening tool (Montreal Cognitive Assessment);
- History of major head trauma as identified through a screening tool (Ohio State University Traumatic Brain Injury Identification Method);
- History of psychosis or other Axis I disorder that is primary;
- Positive screen for bipolar disorder, as identified through a screening tool (The Mood Disorder Questionnaire);
- Life expectancy <1 year;
- Attempt of suicide in the last 2 years;
- 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 pregnancy test;
- Inability or unwillingness of subject or legal guardian/representative to give informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT04263285 · 00086228