rTMS for Depression After Spinal Cord Injury

Overseen By Catherine VanDerwerker, DPT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 21

Duration: 4 weeks

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new way to treat depression in individuals who have experienced a spinal cord injury (SCI). It will use repetitive transcranial magnetic stimulation (rTMS), a non-invasive method that uses magnetic fields to stimulate the brain. The trial will assess whether this treatment is safe and effective in reducing depression symptoms. Ideal participants are those who have had a cervical or thoracic SCI for at least six months, experience depression, and have some movement in their right thumb. If successful, this study could lead to improved depression treatments for those living with SCI. As an unphased trial, participants can contribute to groundbreaking research that may enhance future depression treatments for SCI patients.

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 prior data suggests that this method is safe for treating depression after spinal cord injury?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe and well-tolerated for treating depression. Studies have found that combining rTMS with antidepressants can improve depression symptoms. This indicates that rTMS is both effective and safe to use alongside other treatments.

For individuals with spinal cord injuries (SCI), rTMS has shown promising results. It has been used to enhance movement and reduce pain, suggesting its usefulness and safety in various situations.

While researchers continue to study rTMS specifically for its effects on depression after SCI, its application in general depression and other SCI-related conditions suggests it is well-tolerated, with few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it uses magnetic fields to stimulate nerve cells in the brain, which is different from the typical use of medications or psychotherapy for depression. Most treatments for depression focus on altering brain chemistry through medication, while rTMS targets specific brain regions directly to potentially improve mood and alleviate symptoms. Researchers are excited about rTMS because it offers a non-invasive option with fewer side effects and may work quicker for some patients compared to traditional antidepressants. Additionally, it holds promise for those with depression following a spinal cord injury, where standard treatments might be less effective.

What evidence suggests that rTMS is effective for treating depression after spinal cord injury?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) may help treat depression, especially after a spinal cord injury (SCI). This non-invasive method uses magnetic fields to activate nerve cells in the brain. It has also helped with other SCI-related issues, such as improving movement and reducing pain. Although specific data on using rTMS for depression after SCI is limited, its success in other areas suggests potential benefits. Early studies showed promising results, and this trial aims to confirm its effectiveness for depression in this context. ^{2 4 6 7 8}

Who Is on the Research Team?

Catherine VanDerwerker, DPT, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• rTMS

Trial Overview 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.

How Is the Trial Designed?

Group I: rTMS (Repetitive Transcranial Magnetic Stimulation) Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

The Craig H. Neilsen Foundation

Collaborator

Trials

62

Recruited

3,100+

Published Research Related to This Trial

In a study involving subjects with spinal cord injury (SCI), real repetitive transcranial magnetic stimulation (rTMS) did not show significant differences in the ASIA impairment scale compared to sham treatment, indicating limited efficacy in this specific measure.

However, rTMS did lead to short-term improvements in upper limb function as measured by the Action Research Arm Test (ARAT) and increased motor thresholds, suggesting that electrophysiological measures could be valuable in assessing functional changes in SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Action of 5 Hz repetitive transcranial magnetic stimulation on sensory, motor and autonomic function in human spinal cord injury. Kuppuswamy, A., Balasubramaniam, AV., Maksimovic, R., et al.[2011]

In a study involving 60 rats with partial spinal cord injury, the combination of repetitive transcranial magnetic stimulation (rTMS) and treadmill training (TT) significantly improved motor function compared to other treatment groups, indicating enhanced recovery.

The combined rTMS and TT treatment also led to increased levels of brain-derived neurotrophic factor (BDNF), synapsin I (SYN), and postsynaptic density protein-95 (PSD-95) in both the motor cortex and spinal cord, suggesting that this approach promotes neuroplasticity essential for motor recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) and Treadmill Training on Recovery of Motor Function in a Rat Model of Partial Spinal Cord Injury. Wang, P., Yin, R., Wang, S., et al.[2022]

In a study involving 18 subjects with major depression, repetitive transcranial magnetic stimulation (rTMS) for up to 4 weeks was found to be generally safe, with no significant mean deficits in neuropsychologic function or auditory thresholds.

However, two patients experienced mild high-frequency hearing loss, indicating that while rTMS is safe for most, individual responses may vary and warrant further investigation into long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. Loo, C., Sachdev, P., Elsayed, H., et al.[2019]

Repetitive transcranial magnetic stimulation (rTMS) shows promise as a non-invasive treatment to enhance recovery and functional outcomes in individuals with spinal cord injury (SCI), with potential benefits for motor function and spasticity based on a review of 16 studies.

Future research should focus on optimizing rTMS parameters, such as timing and dosage, and emphasize the need for more rigorous studies comparing real versus sham rTMS to strengthen the evidence for its efficacy in SCI rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation Parameters Used During Repetitive Transcranial Magnetic Stimulation for Motor Recovery and Corticospinal Excitability Modulation in SCI: A Scoping Review. Brihmat, N., Allexandre, D., Saleh, S., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) has been explored as a noninvasive method to enhance recovery of motor and sensory functions in patients with spinal cord injury (SCI), but results have been mixed, with some studies showing improvements while others did not.

The effectiveness of rTMS may depend on specific parameters of the treatment and the extent of post-injury reorganization in the nervous system, indicating a need for more research to optimize its use in rehabilitation for SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation on recovery of function after spinal cord injury. Tazoe, T., Perez, MA.[2021]

In a proof-of-concept study involving three adults with cervical spinal cord injury, repetitive QuadroPulse transcranial magnetic stimulation (rTMS(QP)) showed functional benefits, particularly in improving walking speed and cortical excitability without any adverse effects.

The combination of rTMS(QP) with targeted exercises led to even greater improvements in motor function, suggesting that this approach could be effective and warrants further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of QuadroPulse rTMS for improving motor function after spinal cord injury: Three case studies. Alexeeva, N., Calancie, B.[2018]

High-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the leg motor area significantly reduced lower limb spasticity in patients with incomplete spinal cord injury, with effects lasting for at least one week after treatment.

The study involved 15 patients who underwent 5 days of rTMS sessions, showing that active stimulation led to clinical improvements compared to sham stimulation, although neurophysiological measures did not show changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of spasticity with repetitive transcranial magnetic stimulation in patients with spinal cord injury. Kumru, H., Murillo, N., Samso, JV., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7526137/

Effects of Repetitive Transcranial Magnetic Stimulation on ... Overall, rTMS has been used to target three main consequences of SCI: a) sensory and motor function impairments, b) spasticity, and c) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02899637

Effects of Transcranial Magnetic Stimulation in Incomplete ... In this line of reasoning, protocols involving repetitive transcranial magnetic stimulation (rTMS) have been found effective in enhancing corticospinal synaptic ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772529425000530

nTMS in spinal cord injury: Current evidence, challenges ... nTMS has shown encouraging preliminary results in both clinical assessment and rehabilitation (motor and pain) of patients with SCI.

4. reporter.nih.gov reporter.nih.gov/project-details/10977065

Project Details [This study specifically addresses current limitations in treating depression post- SCI using rTMS and will: (1) identify the target electric-field (e-field) ...

5. mdpi.com mdpi.com/1422-0067/26/2/825

Repetitive Transcranial Magnetic Stimulation for the ... Studies employing rTMS at the primary motor cortex (M1) have demonstrated promising outcomes in improving motor function recovery in both the upper extremity [ ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5925584/

Meta-analysis of the Efficacy and Safety of Repetitive ... After Meta-analysis, we found that treatment combined rTMS with antidepressants improves depressive symptoms in patients with depression.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835319

Repetitive Transcranial Magnetic Stimulation as ... Repetitive transcranial magnetic stimulation (rTMS) as maintenance treatment may prevent relapse of treatment-resistant depression (TRD).

8. nature.com nature.com/articles/s41393-021-00703-8

a randomized controlled trial | Spinal Cord High-frequency rTMS may increase long-term training-induced recovery of lower limb muscle strength following SCI. The effect on short-term recovery is unclear.