rTMS for Spinal Cord Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord Injuries+2 More
rTMS - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Spinal Cord Injuries
  • Depression

Treatment Effectiveness

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: Baseline, midpoint (Week 3), and post treatment (5 weeks)

Week 5
Change in function and daily activities as assessed by the Craig Handicap Assessment and Reporting Tool-Short Form
Spinal Cord
Spinal Cord
Change in subjective well-being based on the Satisfaction With Life Scale.
Week 5
Change depressive symptoms as assessed by the Patient Health Questionnaire-9 score
Mental Depression
Change in depressive symptoms as assessed by the Montgomery- Asberg Depression Rating Scale (MADRS)
Depressive Symptoms
Week 5
Safety as assessed by number of adverse events
Week 4
Number of visits missed

Trial Safety

Side Effects for

Experiment 2: Prefrontal Cortex rTMS Stimulation - 3 Days
50%Intolerance to stimulation
This histogram enumerates side effects from a completed 2020 Phase 1 & 2 trial (NCT03050801) in the Experiment 2: Prefrontal Cortex rTMS Stimulation - 3 Days ARM group. Side effects include: Intolerance to stimulation with 50%.

Trial Design

1 Treatment Group

rTMS (Repetitive Transcranial Magnetic Stimulation)
1 of 1

Experimental Treatment

14 Total Participants · 1 Treatment Group

Primary Treatment: rTMS · No Placebo Group · N/A

rTMS (Repetitive Transcranial Magnetic Stimulation)
Device
Experimental Group · 1 Intervention: rTMS · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rTMS
2008
Completed Phase 3
~750

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, midpoint (week 3), and post treatment (5 weeks)

Who is running the clinical trial?

The Craig H. Neilsen FoundationOTHER
44 Previous Clinical Trials
2,503 Total Patients Enrolled
42 Trials studying Spinal Cord Injuries
2,452 Patients Enrolled for Spinal Cord Injuries
Medical University of South CarolinaLead Sponsor
833 Previous Clinical Trials
5,372,961 Total Patients Enrolled
7 Trials studying Spinal Cord Injuries
131 Patients Enrolled for Spinal Cord Injuries
Catherine VanDerwerker, DPT, PhDPrincipal InvestigatorMedical University of South Carolina

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a spinal cord injury of at least 6 months post-injury.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: November 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.