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NCT04706208 · ClinicalTrials.gov registry record · NA
Identifying Body Awareness-related Brain Network Changes During Cognitive Multisensory Rehabilitation for Reduced Neuropathic Pain in People With Spinal Cord Injury
A NA study, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 58
- Enrollment target
NCT04706208: Completed NA study, sponsored by University of Minnesota.
NCT04706208 is a NA study that has completed, run by University of Minnesota. The registered enrollment target is 58 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04706208, a NA study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 58 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The numeric pain rating scale assesses the highest, lowest and average pain ratings over the past week. The 1-10 numerical pain rating scale has been recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus group for use in pain clinical trials and by the 2006 National Institute on Disability and Rehabilitation Research (NIDRR) SCI Pain outcome measures consensus group. This scale is recommended to standardize pain outcomes across studies.
Interventions
- OTHER Usual Care
- BEHAVIORAL Cognitive Multisensory Therapy
- BEHAVIORAL Clinical Assessment
- BEHAVIORAL Magnetic Resonance Imaging (MRI)
- OTHER OPTIONAL: blood draw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2024-02-29 |
| Phase | NA |
What the finished NCT04706208 record still lists
NCT04706208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 5 interventions - of which Usual Care is the first listed.
NCT04706208 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04706208 about?
NCT04706208 is a clinical study titled "Identifying Body Awareness-related Brain Network Changes During Cognitive Multisensory Rehabilitation for Reduced Neuropathic Pain in People With Spinal Cord Injury". 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 importa...
What is the current status of trial NCT04706208?
This trial is currently completed. It is a NA study. The enrollment target is 58 participants. The study started on 2020-09-01. Estimated completion is 2024-02-29.
What interventions are being tested in trial NCT04706208?
The interventions under investigation include: Usual Care (OTHER), Cognitive Multisensory Therapy (BEHAVIORAL), Clinical Assessment (BEHAVIORAL), Magnetic Resonance Imaging (MRI) (BEHAVIORAL), OPTIONAL: blood draw (OTHER).
Who is sponsoring clinical trial NCT04706208?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04706208's enrollment target sits among peer trials
58 1256th of 2000 higher than 740 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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