Overseen ByCatherine VanDerwerker, DPT, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
Must not be taking: Antidepressants, Anti-seizure, others
Disqualifiers: Neurologic diseases, Dementia, Psychosis, Bipolar, Seizures, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing a new treatment for depression called rTMS in people who have spinal cord injuries. rTMS uses magnets to stimulate the brain. The study will check if this treatment is safe and if it helps reduce depression symptoms. Repetitive transcranial magnetic stimulation (rTMS) has been researched for over 15 years and is considered an effective treatment for depression.
Will I have to stop taking my current medications?
The trial requires that you have not changed your antidepressant or psychotropic medication doses for at least 4 weeks before starting, or 6 weeks if you recently started a new medication. If you meet this condition, you may not need to stop your current medications.
What data supports the effectiveness of the treatment rTMS for depression after spinal cord injury?
Research shows that repetitive transcranial magnetic stimulation (rTMS) can help improve motor function, reduce spasticity (muscle stiffness), and modulate nerve pathways in people with spinal cord injuries. While these studies focus on physical recovery, they suggest that rTMS may have potential benefits for other conditions like depression by influencing brain activity.
12345Is rTMS safe for humans?
Repetitive transcranial magnetic stimulation (rTMS) has been studied for safety in humans, including those with depression, and generally shows a good safety profile. Studies have examined its use over several weeks, indicating it is safe for short-term use, but more research is needed to fully understand its long-term safety, especially in people with spinal cord injuries.
12356How is rTMS treatment different from other treatments for depression after spinal cord injury?
rTMS (repetitive transcranial magnetic stimulation) is unique because it uses magnetic fields to non-invasively stimulate specific areas of the brain, potentially improving sensory, motor, and autonomic functions after spinal cord injury. Unlike traditional drug treatments, rTMS directly targets brain activity, which may help with recovery of function and reduction of spasticity.
12347Eligibility Criteria
This trial is for individuals aged 18-70 who have had a spinal cord injury at the cervical or thoracic level for over 6 months and are experiencing depression. They must be able to move their right thumb, not have started new psychotropic meds in the last 4-6 weeks, and cannot be pregnant or have certain neurological conditions.Inclusion Criteria
I can partially move my right thumb.
I haven't started or changed any antidepressant doses in the last 4-6 weeks.
I had a spinal cord injury at least 6 months ago, in my neck or upper back.
+2 more
Exclusion Criteria
Positive screen for bipolar disorder, as identified through a screening tool (The Mood Disorder Questionnaire)
I have a history of seizures or am on seizure medication.
Attempt of suicide in the last 2 years
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive rTMS treatment five days a week for four weeks
4 weeks
20 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 week
1 visit (in-person)
Participant Groups
The study tests repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain therapy, on those with depression post-spinal cord injury. Participants will receive rTMS five days a week for four weeks to evaluate its safety and effect on depressive symptoms.
1Treatment groups
Experimental Treatment
Group I: rTMS (Repetitive Transcranial Magnetic Stimulation)Experimental Treatment1 Intervention
rTMS is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as rTMS for:
- Obsessive-Compulsive Disorder (OCD)
- Major Depressive Disorder
- Migraines
- Smoking cessation
🇪🇺 Approved in European Union as rTMS for:
- Obsessive-Compulsive Disorder (OCD)
- Major Depressive Disorder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
The Craig H. Neilsen FoundationCollaborator
References
Effects of repetitive transcranial magnetic stimulation on recovery of function after spinal cord injury. [2021]A major goal of rehabilitation strategies after spinal cord injury (SCI) is to enhance the recovery of function. One possible avenue to achieve this goal is to strengthen the efficacy of the residual neuronal pathways. Noninvasive repetitive transcranial magnetic stimulation (rTMS) has been used in patients with motor disorders as a tool to modulate activity of corticospinal, cortical, and subcortical pathways to promote functional recovery. This article reviews a series of studies published during the last decade that used rTMS in the acute and chronic stages of paraplegia and tetraplegia in humans with complete and incomplete SCI. In the studies, rTMS has been applied over the arm and leg representations of the primary motor cortex to target 3 main consequences of SCI: sensory and motor function impairments, spasticity, and neuropathic pain. Although some studies demonstrated that consecutive sessions of rTMS improve aspects of particular functions, other studies did not show similar effects. We discuss how rTMS parameters and postinjury reorganization in the corticospinal tract, motor cortical, and spinal cord circuits might be critical factors in understanding the advantages and disadvantages of using rTMS in patients with SCI. The available data highlight the limited information on the use of rTMS after SCI and the need to further understand the pathophysiology of neuronal structures affected by rTMS to maximize the potential beneficial effects of this technique in humans with SCI.
Efficacy of QuadroPulse rTMS for improving motor function after spinal cord injury: Three case studies. [2018]To examine the effects of repetitive QuadroPulse transcranial magnetic stimulation (rTMS(QP)) on hand/leg function after spinal cord injury (SCI).
Reduction of spasticity with repetitive transcranial magnetic stimulation in patients with spinal cord injury. [2021]Spasticity with increased tone and spasms is frequent in patients after spinal cord injury (SCI). Damage to descending corticospinal pathways that normally exert spinal segmental control is thought to play an important causal role in spasticity. The authors examined whether the modulation of excitability of the primary motor cortex with high-frequency repetitive transcranial magnetic stimulation (rTMS) could modify lower limb spasticity in patients with incomplete SCI.
Action of 5 Hz repetitive transcranial magnetic stimulation on sensory, motor and autonomic function in human spinal cord injury. [2011]To assess the effectiveness of physiological outcome measures in detecting functional change in the degree of impairment of spinal cord injury (SCI) following repetitive transcranial magnetic stimulation (rTMS) of the sensorimotor cortex.
Stimulation Parameters Used During Repetitive Transcranial Magnetic Stimulation for Motor Recovery and Corticospinal Excitability Modulation in SCI: A Scoping Review. [2022]There is a growing interest in non-invasive stimulation interventions as treatment strategies to improve functional outcomes and recovery after spinal cord injury (SCI). Repetitive transcranial magnetic stimulation (rTMS) is a neuromodulatory intervention which has the potential to reinforce the residual spinal and supraspinal pathways and induce plasticity. Recent reviews have highlighted the therapeutic potential and the beneficial effects of rTMS on motor function, spasticity, and corticospinal excitability modulation in SCI individuals. For this scoping review, we focus on the stimulation parameters used in 20 rTMS protocols. We extracted the rTMS parameters from 16 published rTMS studies involving SCI individuals and were able to infer preliminary associations between specific parameters and the effects observed. Future investigations will need to consider timing, intervention duration and dosage (in terms of number of sessions and number of pulses) that may depend on the stage, the level, and the severity of the injury. There is a need for more real vs. sham rTMS studies, reporting similar designs with sufficient information for replication, to achieve a significant level of evidence regarding the use of rTMS in SCI.
Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. [2019]The safety of repetitive transcranial magnetic stimulation (rTMS) has only previously been formally studied in volunteers receiving a single session of stimulation or in a small number of depressed subjects receiving a 2-week treatment course. This study examined safety issues in depressed subjects receiving up to 4 weeks of rTMS. Efficacy results from this study have been previously reported.
Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) and Treadmill Training on Recovery of Motor Function in a Rat Model of Partial Spinal Cord Injury. [2022]BACKGROUND This study aimed to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) and treadmill training (TT) on motor function recovery in rats with partial spinal cord injury (SCI). MATERIAL AND METHODS Sixty rats with moderate partial SCI at the 9th thoracic vertebral level induced by a Louisville Injury System Apparatus impactor were randomly allocated to 5 groups: Sham surgery (Intact); Sham rTMS without TT (S-rTMS/Non-TT); Sham rTMS with TT (S-rTMS/TT); rTMS without TT (rTMS/Non-TT); and rTMS with TT (rTMS/TT). Interventions commenced 8 days after SCI and continued for 8 weeks. Outcomes studied were Basso, Beattie, and Bresnahan locomotor scale scores, grid walking test, and biochemical analysis of the brain-derived neurotrophic factor (BDNF), synapsin I (SYN), and postsynaptic density protein-95 (PSD-95) in the motor cortex and spinal cord. RESULTS The rTMS/TT contributed to greater Basso, Beattie, and Bresnahan scores compared with the S-rTMS/Non-TT (P