What side effects are associated with this type of intervention?

Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation treatment for depression. Known side effects of rTMS are generally mild and may include headaches, scalp discomfort at the stimulation site, tingling, spasms or twitching of facial muscles, and lightheadedness. Serious side effects are rare but can include seizures. Other non-invasive treatments like transcranial direct-current stimulation (tDCS) may cause similar mild side effects such as skin irritation and tingling sensations.

What prior FDA approvals exist?

Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation technique that has received FDA approval for the treatment of major depressive disorder, particularly in patients who have not responded to traditional antidepressant medications. This method involves using magnetic fields to stimulate nerve cells in the brain, which can improve symptoms of depression. Other FDA-approved treatments for depression include various pharmacological options such as SSRIs, SNRIs, and atypical antipsychotics, as well as electroconvulsive therapy (ECT) for more severe cases. rTMS offers a promising alternative for patients seeking non-pharmacological interventions.

What other types of research exist?

Promising, novel alternatives to rTMS for depression include transcutaneous supraorbital nerve stimulation and noninvasive vagus nerve stimulation (nVNS). Both have shown efficacy in clinical trials for other conditions and may be considered for depression treatment.

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Non-invasive Brain Stimulation

rTMS for Depression After Spinal Cord Injury

N/A

Recruiting

Led By Catherine VanDerwerker, DPT, PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have at least partial active movement of the right thumb (abductor pollicis brevis) to allow for FDA approved rTMS dosing

Age 18 - 70

Must not have

History of seizures or currently prescribed anti-seizure medications

Inability or unwillingness of subject or legal guardian/representative to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, midpoint (week 3), and post treatment (5 weeks)

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of rTMS may include discomfort at the treatment site, headache, lightheadedness, seizures (though rare), or changes in hearing if ear protection isn't used during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can partially move my right thumb.

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I am between 18 and 70 years old.

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I have been diagnosed with major depressive disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures or am on seizure medication.

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I cannot or do not want to give consent for the trial.

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I am on medication that could increase my risk of seizures.

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I have a neurological condition or dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, midpoint (week 3), and post treatment (5 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, midpoint (week 3), and post treatment (5 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, midpoint (week 3), and post treatment (5 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mental Depression

Number of visits missed

Safety as assessed by number of adverse events

Secondary study objectives

Change depressive symptoms as assessed by the Patient Health Questionnaire-9 score

Change in depressive symptoms as assessed by the Montgomery- Asberg Depression Rating Scale (MADRS)

Change in function and daily activities as assessed by the Craig Handicap Assessment and Reporting Tool-Short Form

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: rTMS (Repetitive Transcranial Magnetic Stimulation)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rTMS

2016

Completed Phase 3

~840

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation technique that uses magnetic fields to stimulate nerve cells in the brain, particularly targeting the dorsolateral prefrontal cortex, which is involved in mood regulation. This stimulation can help improve neural connectivity and activity in areas that are underactive in depression. Other common treatments include pharmacotherapy, which involves medications like SSRIs and SNRIs that increase the levels of neurotransmitters such as serotonin and norepinephrine to improve mood, and psychotherapy, such as Cognitive Behavioral Therapy (CBT), which helps patients change negative thought patterns and behaviors. Understanding these mechanisms is crucial for depression patients as it helps them and their healthcare providers make informed decisions about treatment options, potentially leading to more effective and personalized care.