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Multisensory Body-Representation Therapy for Spinal Cord Injury Pain

N/A

Recruiting

Led By Eva Widerstrom-Noga, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

Experiencing persistent neuropathic pain for a minimum of three months prior to entering the study, with severity of at least 4 on a Numeric Rating Scale (NRS) ranging 0 to 10

Aged 18-70 with complete and incomplete SCI, level of injury above L1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to 4 weeks

Awards & highlights

Study Summary

This trial will investigate if body illusions and electrical stimulation can reduce pain and improve sensory functions in people with spinal cord injury and neuropathic pain.

Who is the study for?

This trial is for English-speaking men and women aged 18-70 who have a spinal cord injury above the L1 level and suffer from persistent neuropathic pain of at least moderate severity. Candidates should not have epilepsy, major psychiatric disorders, other significant neurological trauma, recent substance abuse issues, uncorrected vision or hearing loss, or certain metal implants.Check my eligibility

What is being tested?

The study is testing whether combining bodily illusions with a brain stimulation technique called transcranial direct current stimulation (tDCS) can reduce neuropathic pain and improve sensory functions in people with spinal cord injuries.See study design

What are the potential side effects?

Potential side effects may include discomfort at the electrode site on the head during tDCS, mild headaches or itching under the electrodes, fatigue after treatment sessions, and temporary changes in skin sensation.

Eligibility Criteria

Inclusion Criteria

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

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I have had nerve pain for at least 3 months, with a pain level of 4 or more.

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I am between 18 and 70 years old with a spinal cord injury above L1.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, up to 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 4 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

Change in neuropathic pain interference assessed by pain interference questionnaire.

Change in neuropathic pain severity assessed by Neuropathic Pain Symptom Inventory (NPSI)

Changes associated with sensory function/dysfunction assessed by quantitative sensory testing

Secondary outcome measures

Change in Global impression of changes by PGIC questionnaire

Change in manageable pain assessed by days of manageable pain questionnaire.

Changes of psychosocial assessed by Multidimensional Pain Inventory (pain severity subscale)

Trial Design

1Treatment groups

Experimental Treatment

Group I: SCI with painExperimental Treatment1 Intervention

Participants will undergo 2-4 weeks of combined intervention including transcranial direct current stimulation (tDCS) and bodily illusions (10 sessions total).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

902 Previous Clinical Trials

410,046 Total Patients Enrolled

Eva Widerstrom-Noga, PhDPrincipal InvestigatorUniversity of Miami

Frequently Asked Questions

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

What prerequisites must be met to enter this research program?

"The requirements to partake in this study include a spinal cord injury and an age range between 18-70 years old. 30 applicants may ultimately be selected for the trial."

Answered by AI

Are participants of legal age being welcomed into this medical trial?

"The clinical trial is open to those aged 18-70; however, there are separate trials available for people younger than 18 and older than 65 years old. Specifically, 45 studies exist for minors while 433 research projects are accepting seniors as participants."

Answered by AI

Does this research have any current availability for participants?

"As depicted on clinicaltrials.gov, recruitment for this trial has ceased as of August 18th 2023. The study was posted initially in November 2023 and there are currently 492 other trials actively searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Utility of Multisensory Body-Representation in Spinal Cord Injury (SCI) With Pain

Eva Widerstrom-Noga 2023. "Utility of Multisensory Body-Representation in Spinal Cord Injury (SCI) With Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06010251.

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