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

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 5 6}

How 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. ^{1 2 3 4 7}

Research Team

Catherine VanDerwerker, DPT, PhD

Principal Investigator

Medical University of South Carolina

Eligibility 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.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation on recovery of function after spinal cord injury. [2021]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Reduction of spasticity with repetitive transcranial magnetic stimulation in patients with spinal cord injury. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Action of 5 Hz repetitive transcranial magnetic stimulation on sensory, motor and autonomic function in human spinal cord injury. [2011]

5. Switzerland 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. [2022]

6. United States 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. [2019]

7. United States 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. [2022]