Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
24 participants
INTERVENTIONAL
2025-03-31
2027-10-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Depression Post-SCI
NCT04263285
TMS in the Treatment of the Sequelae of Closed Brain Injury
NCT00531258
The Effectiveness of rTMS in Depressed VA Patients
NCT01191333
rTMS for PTSD Comorbid With Major Depressive Disorder
NCT02273063
REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN the Treatment of DEPRESSION
NCT00220610
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Repetitive transcranial magnetic stimulation (rTMS), a type of non-invasive brain stimulation, is an FDA-approved treatment option for major depressive disorder (MDD) that is utilized throughout the Veterans Affairs (VA) health system. However, to date, no published studies have examined its effectiveness post-SCI. A critical challenge for widespread administration of rTMS for depression post-SCI is dosing, as the resting motor threshold (rMT), a motor response to transcranial magnetic stimulation (TMS), of the right abductor pollicis brevis (APB) is used to dose rTMS. Approximately 60% of the SCI population has incomplete or complete tetraplegia, indicating some degree of upper extremity (UE) impairment, making rMT not reliably attainable. Thus, it is plausible to conclude that over half the SCI population could be excluded from receiving rTMS treatment for depression or may receive an improper dose, impacting its safety and effectiveness. This represents a major gap in the field of SCI rehabilitation in that a large portion of individuals with SCI have concurrent MDD. As such, evidence-based treatment options are necessary to address the needs of this large clinical cohort, thereby improving the lives of these Veterans, their caregivers, and their families.
This study will examine the potential of rTMS, dosed by reverse-calculation electric-field modeling, to improve depressive symptoms in individuals with MDD post-SCI via a randomized, 2-arm, sham-controlled pilot clinical trial. Over four years, twenty-four individual post-SCI with MDD will be enrolled and randomized to receive 6 weeks (5 sessions/week) of either active or sham rTMS treatment. Using an unbalanced design, a quarter of the sample (n=6) randomized to the sham group and the remainder (n=18) randomized to receive active rTMS. Dosing parameters will follow the FDA-approved protocol of 3,000 pulses/session at 10Hz, and intensity will be determined by reverse-calculation electric-field modeling. The primary outcome measure for this study will be the Hamilton Rating Scale for Depression-17. Participants will also complete a 12- and 24-week post-intervention follow-up assessments. It is hypothesized that rTMS treatment dosed using reverse-calculation electric-field modeling will result in a moderate between-group effect size favoring the anti-depressant benefits of rTMS treatment (vs. sham).
In addition to its established anti-depressive effects, rTMS has also been shown to improve patient-reported outcomes such as quality of life and depression-related disability. An extremely exciting possibility is that effective treatment of MDD results in a virtuous cycle whereby reducing depression concomitantly facilitates improvements in other psychosocial domains. The second aim seeks to explore this possibility by determining the extent to which improvements in depressive symptoms are associated with changes in quality of life and participation in Veterans post-SCI with MDD. This trial is an essential step toward optimizing SCI rehabilitation, while simultaneously providing a unique opportunity to study the effects of depression on psychosocial responses to rehabilitation.
The data generated could inform the development of additional interventions focused on neuromodulation to improve function and quality of life for individuals following SCI and other clinical cohorts with upper extremity motor impairment, (e.g., traumatic brain injury, multiple sclerosis, amputees) who otherwise may not be able to benefit from the anti-depressant effects of rTMS treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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.
TREATMENT
TRIPLE
* 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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
repetitive transcranial magnetic stimulation--Active
Repetitive transcranial magnetic stimulation (rTMS) is a type of non-invasive brain stimulation. An active coil will be used to administer the active rTMS.
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.
repetitive transcranial magnetic stimulation--Sham
Repetitive transcranial magnetic stimulation (rTMS) is a type of non-invasive brain stimulation. A sham coil will be used to administer the sham rTMS.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
repetitive transcranial magnetic stimulation--Active
Repetitive transcranial magnetic stimulation (rTMS) is a type of non-invasive brain stimulation. An active coil will be used to administer the active rTMS.
repetitive transcranial magnetic stimulation--Sham
Repetitive transcranial magnetic stimulation (rTMS) is a type of non-invasive brain stimulation. A sham coil will be used to administer the sham rTMS.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
VA Office of Research and Development
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Catherine J VanDerwerker, PhD DPT PT
Role: PRINCIPAL_INVESTIGATOR
Ralph H. Johnson VA Medical Center, Charleston, SC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D3972-W
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.