Identifying Body Awareness-related Brain Network Changes During Cognitive Multisensory Rehabilitation for Reduced Neuropathic Pain in People With Spinal Cord Injury

University of Minnesota (UMN)

Status: Completed

Conditions: Spinal Cord Injuries; Neuropathic Pain

Treatments: Behavioral: Clinical Assessment; Behavioral: Magnetic Resonance Imaging (MRI); Other: OPTIONAL: blood draw; Behavioral: Cognitive Multisensory Therapy; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04706208

PMR-2020-29297

Details and patient eligibility

About

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.

Full description

One of the reasons for the current lack of effective therapies is that underlying mechanisms of neuropathic pain after SCI are not yet fully understood. Nonetheless, as suggested by numerous studies, because of the spinal injury, the inflow of sensory information is dramatically altered. Therefore, the brain is missing sensory information or receiving incorrect sensory information, which may alter the brain circuitry related to pain sensation, which in turn may drive the perception of neuropathic pain.

Cognitive multisensory rehabilitation (CMR), developed for motor recovery after stroke, has shown to be effective for treating adults with chronic pain, i.e., after shoulder impingement when compared to traditional physical therapy; or in a case study of severe phantom limb pain after below the knee amputation, resulting in such substantial pain reduction that the patient could finally be fitted with a prosthesis and walk. CMR is thought to be effective because it restores mental body representations by recalibrating sensations in combination with a focus on body awareness. Body awareness is often impaired in people with chronic pain and with dysfunctions in the sensory and motor networks, such as after SCI.

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.

More information: https://med.umn.edu/rehabmedicine/research/sci-neuropathic-pain

Enrollment: 58 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

SCI participants:

• SCI of ≥ 3months
• medically stable with paraplegia (ASIA grade A-C, who can self-transfer with some assistance)
• neuropathic pain (>3 on the numeric pain rating scale)

Able-bodied participants:

• sex and age matched
• healthy, able-bodied

Exclusion criteria

• MRI contra-indications (stabilizing hardware is typically MRI safe) including seizures, cognitive impairment, or other major medical complications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 3 patient groups

One time testing - able-bodied healthy adults

Other group

Description:

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.

Treatment:

Other: OPTIONAL: blood draw

Behavioral: Magnetic Resonance Imaging (MRI)

Behavioral: Clinical Assessment

Usual Care, then Cognitive Multisensory Therapy - adults with spinal cord injury + neuropathic pain.

Experimental group

Description:

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.

Treatment:

Other: Usual Care

Behavioral: Cognitive Multisensory Therapy

Other: OPTIONAL: blood draw

Behavioral: Magnetic Resonance Imaging (MRI)

Behavioral: Clinical Assessment

Cognitive Multisensory Therapy, then Usual Care - adults with spinal cord injury + neuropathic pain.

Experimental group

Description:

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.

Treatment:

Other: Usual Care

Behavioral: Cognitive Multisensory Therapy

Other: OPTIONAL: blood draw

Behavioral: Magnetic Resonance Imaging (MRI)

Behavioral: Clinical Assessment