Cognitive Multisensory Rehabilitation for Neuropathic Pain

Recruiting in Palo Alto (17 mi)

Overseen byAnn Van de Winckel, Van de Winckel

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Minnesota

No Placebo Group

Trial Summary

What is the purpose of this trial?

Many adults with spinal cord injury (SCI) suffer from long-term debilitating neuropathic pain. Available treatments, including opioids, are ineffective at eliminating this pain. Based on preliminary data from Dr Morse and from Dr Van de Winckel, we have demonstrated that brain areas that are important for body awareness and pain perception (parietal operculum, insula) have weaker brain connectivity in adults with spinal cord injury than in able-bodied healthy adults and that Cognitive Multisensory Rehabilitation (CMR) can restore these networks. This study uses a delayed treatment arm phase I randomized controlled trial (RCT) for adults with SCI and a comparison of baseline outcomes in adults with SCI vs able-bodied healthy adults to address two aims: AIM 1: Determine baseline differences in resting-state and task-based fMRI activation and connectivity in adults with SCI compared to able-bodied healthy controls. AIM 2: Identify changes in brain activation and connectivity, as well as behavioral outcomes in pain and body awareness in adults with SCI after CMR versus standard of care.

Research Team

Ann Van de Winckel, Van de Winckel

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for adults with spinal cord injury (SCI) who've had it for at least 3 months, can self-transfer with some help, and suffer from neuropathic pain. Healthy able-bodied adults can also participate as controls. People cannot join if they have conditions that make MRI unsafe like seizures or cognitive impairments.

Inclusion Criteria

I have had a spinal cord injury for over 3 months, can move with some help, and experience significant nerve pain.

I am healthy and my age and sex match the study's requirements.

Exclusion Criteria

You cannot have an MRI due to certain medical conditions like seizures or cognitive impairment.

Treatment Details

Interventions

Cognitive Multisensory Rehabilitation (Behavioural Intervention)

Trial OverviewThe study tests Cognitive Multisensory Rehabilitation (CMR) against usual care in SCI patients to see if CMR improves brain connectivity and reduces pain. It involves MRIs to observe brain changes and may include a blood draw.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Usual Care, then Cognitive Multisensory Therapy - adults with spinal cord injury + neuropathic pain.Experimental Treatment5 Interventions

This is a delayed treatment arm phase I randomized controlled trial (RCT) for participants with spinal cord injury and neuropathic pain. Participants in this arm will first receive usual care and then switch over to the experimental cognitive multisensory therapy training.

Group II: One time testing - able-bodied healthy adultsExperimental Treatment3 Interventions

Participants in this arm will be able-bodied healthy adults who will not receive an intervention. This is just a one time testing of clinical assessments (over zoom), one MRI scan, and an optional blood draw test.

Group III: Cognitive Multisensory Therapy, then Usual Care - adults with spinal cord injury + neuropathic pain.Experimental Treatment5 Interventions

This is a delayed treatment arm phase I randomized controlled trial (RCT) for participants with spinal cord injury and neuropathic pain. Participants in this arm will first receive the experimental cognitive multisensory therapy training and then switch over to usual care.