RECRUITING

Dosing rTMS for Depression Post-SCI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluating a Novel Method to Determine the rTMS Dose Needed for Treating Depression After Spinal Cord Injury

Quick Facts

Study Start:2025-02-07
Study Completion:2027-10-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05553353

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * cervical or thoracic spinal cord injury at least 6 months prior with AIS A, B, C, or D;
  2. * major depressive disorder, as identified by Structured Clinical Interview for DSM-V;
  3. * Hamilton Depression Rating Scale-17 score \> 18;
  4. * 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)
  1. * concomitant neurologic diseases/disorders or dementia;
  2. * cognitive impairment (Montreal Cognitive Assessment \<17);
  3. * history of psychosis or other Axis I disorder that is primary;
  4. * positive screen for bipolar disorder through the Mini-International Neuropsychiatric Interview;
  5. * history of claustrophobia;
  6. * life expectancy \<1 year;
  7. * electronic or metallic implants (i.e., metal in the head, cochlear implant, or pacemaker;
  8. * history of seizures or currently prescribed anti-seizure medications;
  9. * taking medication that increases the risk of seizures;
  10. * pregnancy as identified through a positive urine pregnancy test;
  11. * Hamilton Depression Rating Scale-17 question #3 regarding suicide: \>2 or suicide attempt within the previous two years;
  12. * inability to (University of California, San Diego Brief Assessment of Capacity to Consent) or declined to give informed consent.

Contacts and Locations

Study Contact

Catherine J VanDerwerker, PhD DPT PT
CONTACT
(843) 792-5047
catherine.vanderwerker@va.gov
Sarah A Jackson, BA MA
CONTACT
(843) 789-6700
sarah.jackson@va.gov

Principal Investigator

Catherine J VanDerwerker, PhD DPT PT
PRINCIPAL_INVESTIGATOR
Ralph H. Johnson VA Medical Center, Charleston, SC

Study Locations (Sites)

Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Catherine J VanDerwerker, PhD DPT PT, PRINCIPAL_INVESTIGATOR, Ralph H. Johnson VA Medical Center, Charleston, SC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-07
Study Completion Date2027-10-29

Study Record Updates

Study Start Date2025-02-07
Study Completion Date2027-10-29

Terms related to this study

Keywords Provided by Researchers

  • Spinal Cord Injuries
  • Depression
  • Depressive Disorder, Major
  • Transcranial Magnetic Stimulation

Additional Relevant MeSH Terms

  • Spinal Cord Injuries
  • Depression
  • Depressive Disorder, Major