Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dosing rTMS for Depression Post-SCI--Phase 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05553353
Recruitment Status : Not yet recruiting
First Posted : September 23, 2022
Last Update Posted : September 23, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Depression Depressive Disorder, Major Device: repetitive transcranial magnetic stimulation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will:

  1. undergo high-resolution T1- and T2-weighted MRI scanning. These images will be used for image guided TMS assessments and e-field calculations for rTMS intensity.
  2. undergo rTMS to the left dorsolateral prefrontal cortex (DLPFC) as a treatment approach for depression. Treatment (active or sham) will be performed five times/week for six weeks (30 sessions). A total of 3,000 pulses/session will be delivered at 10Hz (4 seconds on and 26 seconds off) for a total of 75 stimulation cycles that lasts 37.5 minutes. The intensity will be individualized, as it will be based on reverse-calculation electric-field modeling. Participants receiving sham stimulation will undergo the same procedures as active rTMS except that a coil specifically designed to provide sham stimulation that is double-blinded will be utilized.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
  • Participants will be blinded to group (active vs. sham) assignments.
  • The assessor performing the resting motor threshold (rMT) testing will be blinded to any pre-determined electric-field modeling values or group assignments.
  • Staff member applying the rTMS treatment will be blinded, and an unblinded study staff member will set up the appropriate coil (active vs. sham) prior to each treatment session.
  • The staff member completing outcome assessments will be blinded to participant group assignments.
  • During the immediate post-testing session, the staff members applying the rTMS treatments and those completing the outcome assessments, as well as each participant, will be asked if they think active or sham treatment was received. This will allow for post-hoc assessment on blinding.
  • Unblinding will only occur in the case of a medical emergency or after all follow-up testing has been completed.
Primary Purpose: Treatment
Official Title: Evaluating a Novel Method to Determine the rTMS Dose Needed for Treating Depression After Spinal Cord Injury
Estimated Study Start Date : October 2, 2023
Estimated Primary Completion Date : March 1, 2027
Estimated Study Completion Date : September 1, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active rTMS
Active repetitive transcranial magnetic stimulation (rTMS) that will be administered 5 days/week for 6 weeks. Intensity will be individualized based on reverse-calculation electric-field modeling.
Device: repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS) is a type of non-invasive brain stimulation that is an FDA approved technique to treat depression.
Other Name: rTMS

Sham Comparator: Sham rTMS
Sham repetitive transcranial magnetic stimulation (rTMS) that will be administered 5 days/week for 6 weeks. Intensity will be individualized based on reverse-calculation electric-field modeling, but a sham treatment coil will be used; thus, no active treatment will be administered.
Device: repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS) is a type of non-invasive brain stimulation that is an FDA approved technique to treat depression.
Other Name: rTMS




Primary Outcome Measures :
  1. Change from baseline in Hamilton Depression Rating Scale-17 (HAM-D17) score immediately post-intervention [ Time Frame: Baseline; Following Week 2 of 6-week intervention Following Week 4 of 6-week intervention; Immediately post-intervention; 12-weeks post-intervention; 24-weeks post-intervention ]
    The Hamilton Rating Scale for Depression (HAM-D17) is the most widely used tool to assess the severity of depressive symptoms, once diagnosed, and will be used in this study. The HAM-D17 is a semi-structured interview style questionnaire that asks about one's experience with seventeen different depressive symptoms over the past week. Total HAM-D17 scores range from no depressive symptoms (HAM-D17 = 0-7); mild (HAM-D17 = 8-16), moderate (HAM-D17 = 17-23) or severe depressive symptoms (HAMD-D17 = 24).


Secondary Outcome Measures :
  1. Change from baseline in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) at timepoints noted below [ Time Frame: Baseline; Following Week 2 of 6-week intervention Following Week 4 of 6-week intervention; Immediately post-intervention; 12-weeks post-intervention; 24-weeks post-intervention ]
    The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) is a 16-item questionnaire that asks about the degree of enjoyment and satisfaction in various are of daily functioning, like physical health/activity, mood, work, household duties, school/coursework, leisure time activity, and social relationships. Answers are scored from 1 (very poor) to 5 (very good). It is a valid and reliable measure often used in psychiatric research but has been used in SCI research for neuropathic pain.

  2. Change from baseline in Sheehan Disability Scale (SDS) Score at timepoints noted below [ Time Frame: Baseline; Following Week 2 of 6-week intervention Following Week 4 of 6-week intervention; Immediately post-intervention; 12-weeks post-intervention; 24-weeks post-intervention ]
    Sheehan Disability Scale (SDS): The SDS is a three-item questionnaire that asks how depressive symptoms have impacted work/school, social, and family. It is based on a 10-point scale, where 0 = no disruption to 10 = extreme disruption. This outcome use used in the only randomized control trial for an antidepressant post-SCI.

  3. Change from baseline in Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) Score at timepoints noted below [ Time Frame: Baseline; Following Week 2 of 6-week intervention Following Week 4 of 6-week intervention; Immediately post-intervention; 12-weeks post-intervention; 24-weeks post-intervention ]
    Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) is used to assess physical activity levels of individuals with a spinal cord injury. This is a 3-item questionnaire that asks one to report the number of days and minutes of mild, moderate, and heavy-intensity leisure-time physical activity performed over the previous seven days. This is a valid and reliable measure in the SCI population.

  4. Change from baseline in Craig Handicap Assessment and Reporting Tool - Short Form (CHART-SF) Score at timepoints noted below [ Time Frame: Baseline; Following Week 2 of 6-week intervention Following Week 4 of 6-week intervention; Immediately post-intervention; 12-weeks post-intervention; 24-weeks post-intervention ]
    Craig Handicap Assessment and Reporting Tool - Short Form (CHART-SF) assesses how an individual with a disability fulfills roles in six domains, physical independence, cognitive independence, mobility, occupation, social integration, and economic self-sufficiency. It is a valid and reliable measure post-SCI.

  5. Change from baseline in Reintegration to Normal Living Index (RNL) Score at timepoints noted below [ Time Frame: Baseline; Following Week 2 of 6-week intervention Following Week 4 of 6-week intervention; Immediately post-intervention; 12-weeks post-intervention; 24-weeks post-intervention ]
    The Reintegration to Normal Living Index (RNL) is an 11-item questionnaire that assesses one's satisfaction with their performance of mobility, self-care, daily activity, recreational activity, and family roles.

  6. Change from baseline Hamilton Depression Rating Scale-17 (HAM-D17) Score at timepoints noted below [ Time Frame: Baseline; Following Week 2 of 6-week intervention Following Week 4 of 6-week intervention; 12-weeks post-intervention; 24-weeks post-intervention ]
    The Hamilton Rating Scale for Depression (HAM-D17) is the most widely used tool to assess the severity of depressive symptoms, once diagnosed, and will be used in this study. The HAM-D17 is a semi-structured interview style questionnaire that asks about one's experience with seventeen different depressive symptoms over the past week. Total HAM-D17 scores range from no depressive symptoms (HAM-D17 = 0-7); mild (HAM-D17 = 8-16), moderate (HAM-D17 = 17-23) or severe depressive symptoms (HAMD-D17 = 24).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05553353


Contacts
Layout table for location contacts
Contact: Rutha A LaRue (843) 789-6707 Rutha.Larue@va.gov
Contact: Sarah A Jackson, BA MA (843) 789-6700 sarah.jackson@va.gov

Locations
Layout table for location information
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799
Contact: Rutha A LaRue    843-789-6707    Rutha.Larue@va.gov   
Contact: Sarah A Jackson, BA MA    (843) 789-6700    sarah.jackson@va.gov   
Principal Investigator: Catherine VanDerwerker, PT DPT PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Catherine VanDerwerker, PT DPT PhD Ralph H. Johnson VA Medical Center, Charleston, SC
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT05553353    
Other Study ID Numbers: D3972-W
1IK2RX003972-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2022    Key Record Dates
Last Update Posted: September 23, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Spinal Cord Injuries
Depression
Depressive Disorder, Major
Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Depression
Depressive Disorder
Depressive Disorder, Major
Wounds and Injuries
Behavioral Symptoms
Mood Disorders
Mental Disorders
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System