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Non-invasive Brain Stimulation

rTMS for Depression Post-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

At least 6 months post incomplete cervical or incomplete or complete thoracic level SCI

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

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will investigate the safety and efficacy of a new treatment for depression in people with spinal cord injuries.

Eligible Conditions

Depression
Spinal Cord Injury

Eligibility Criteria

Inclusion Criteria

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

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You have had a spinal cord injury in the cervical or thoracic area at least 6 months ago.

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You need to be able to move your right thumb at least a little bit to receive the approved treatment.

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You have been diagnosed with major depressive disorder using specific tests.

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You haven't taken any antidepressant or changed your psychotropic medication for at least 4 weeks before the study (6 weeks if you just started a new medication).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mental Depression

Number of visits missed

Safety as assessed by number of adverse events

Secondary outcome measures

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

911 Previous Clinical Trials

7,366,811 Total Patients Enrolled

40 Trials studying Depression

6,939 Patients Enrolled for Depression

The Craig H. Neilsen FoundationOTHER

52 Previous Clinical Trials

2,775 Total Patients Enrolled

Catherine VanDerwerker, DPT, PhDPrincipal InvestigatorMedical University of South Carolina

Media Library

rTMS (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04263285 — N/A

Depression Research Study Groups: rTMS (Repetitive Transcranial Magnetic Stimulation)

Depression Clinical Trial 2023: rTMS Highlights & Side Effects. Trial Name: NCT04263285 — N/A

rTMS (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04263285 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial permit seniors of over 70 years to participate?

"The age range criterion for this medical trial is between 18 and 70 years old."

Answered by AI

Am I eligible to take part in this scientific experiment?

"This clinical investigation is enrolling 14 individuals with spinal cord injuries ranging from 18 to 70 years old. The following criteria must be met for consideration: age between 18 and 70, partial active movement of the right thumb (abductor pollicis brevis), no changes in psychotropic medications within a 4-6 week period prior to the trial's commencement."

Answered by AI

What purpose does this clinical trial seek to fulfill?

"The primary aim of this clinical trial, which will be evaluated at its Baseline, Week 3 midpoint and post-treatment 5 week conclusion is to assess the safety through potential adverse events. Secondary objectives include determining how depressive symptoms have impacted an individual's quality of life with the Sheehan Disability Scale (0 - 30 score range), Craig Handicap Assessment and Reporting Tool-Short Form self-report questionnaire (19 questions) as well as a subject's subjective wellbeing via Satisfaction With Life Scale responses from 1 to 7."

Answered by AI

Is there still room for participants in this experiment?

"Affirmative. Data on clinicaltrials.gov confirms that the trial, which was initially posted on November 1st 2022, is actively enrolling patients. The research team expects to include 14 individuals from one medical centre in this study."

Answered by AI

What is the aggregate number of participants in this medical study?

"Affirmative. According to clinicaltrials.gov, this research endeavour is actively searching for participants. Initially posted on the 1st of November 2022 and last updated on July first 2022; the trial seeks to recruit 14 patients at a single medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Depression Post-SCI

Catherine VanDerwerker 2023. "Treatment of Depression Post-SCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04263285.

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