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

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University of Miami

Status

Enrolling

Conditions

Spinal Cord Injuries
Neuropathic Pain

Treatments

Other: tDCS and bodily illusions

Study type

Interventional

Funder types

Other

Identifiers

NCT06010251
20230447
SC220073 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to investigate the effectiveness of bodily illusions combined with transcranial direct current stimulation (tDCS) on neuropathic pain symptoms and sensory functions in participants with spinal cord injury (SCI) and neuropathic pain.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

The study will be open to people of any ethnicity, racial background, and gender.

Inclusion criteria:

SCI with Pain:

  1. Men or women
  2. fluent in English
  3. 18-70 years of age who have: (3a) Complete and incomplete SCI, level of injury (above L1); (3b) Persistent neuropathic pain started after the injury for a minimum of three months prior to entering the study that is at least moderate in severity, defined as ≥ 4 on a Numeric Rating Scale (NRS) ranging 0 to 10.

Exclusion criteria:

Participants will be excluded if they have:

  1. Major psychiatric disease/disorder (self-reported);
  2. a significant neurological trauma (self-reported) other than SCI;
  3. a recent (one-year) history of alcohol or drug abuse assessed by the Drug Abuse Screening Test (DAST-10)
  4. history of visual and hearing loss not corrected
  5. history of epilepsy or seizures
  6. any metal implants in the head, or implanted devices such as cochlea implants or cardiac pacemakers.

We will not include any special population like:

Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

SCI with pain
Experimental group
Description:
Participants will undergo 2-4 weeks of combined intervention including transcranial direct current stimulation (tDCS) and bodily illusions (10 sessions total).
Treatment:
Other: tDCS and bodily illusions

Trial contacts and locations

1

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Central trial contact

Eva Widerstrom-Noga, PhD; Roberta Vastano, PhD

Data sourced from clinicaltrials.gov

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