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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

Must not have

History of epilepsy or seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to 4 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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 epilepsy or seizures.

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

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

Primary study objectives

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 study objectives

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)

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: 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 / 3Eligibility criteria met