Dosing rTMS for Depression Post-SCI

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.

Conditions

Spinal Cord Injuries, Depression, Depressive Disorder, Major

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

Dosing rTMS for Depression Post-SCI

Condition
Spinal Cord Injuries
Intervention / Treatment

-

Contacts and Locations

Charleston

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * cervical or thoracic spinal cord injury at least 6 months prior with AIS A, B, C, or D;
  • * 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.

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2027-10-29