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Behavioural Intervention

Cognitive Multisensory Rehabilitation for Neuropathic Pain

N/A
Waitlist Available
Led By Ann Van de Winckel, Van de Winckel
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
SCI participants: SCI of ≥ 3 months, medically stable with paraplegia (ASIA grade A-C, who can self-transfer with some assistance), neuropathic pain (>3 on the numeric pain rating scale)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
Awards & highlights

Study Summary

This trial will help to determine if CMR is an effective treatment for reducing neuropathic pain in adults with SCI by looking at changes in brain activation and connectivity.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
There are no direct side effects mentioned for the Cognitive Multisensory Therapy itself; however, an MRI may cause discomfort or anxiety in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a spinal cord injury for over 3 months, can move with some help, and experience significant nerve pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
International SCI Basic Pain Data Set
Pain Numeric Rating Scale (NPRS) - part of the International SCI Basic Pain Data Set
Secondary outcome measures
Moorong Self-Efficacy Scale (MSES)
Patient Health Questionnaire (PHQ-9)
Patient Specific Functional Scale
+7 more

Trial Design

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 cross-over study 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 cross-over study 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
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Multisensory Therapy
2020
N/A
~60
Clinical Assessment
2021
N/A
~2450
Magnetic Resonance Imaging (MRI)
2015
Completed Phase 4
~1800

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,379 Previous Clinical Trials
1,588,465 Total Patients Enrolled
2 Trials studying Neuropathic Pain
40 Patients Enrolled for Neuropathic Pain
Ann Van de Winckel, Van de WinckelPrincipal InvestigatorUniversity of Minnesota

Media Library

Cognitive Multisensory Rehabilitation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04706208 — N/A
Neuropathic Pain Research Study Groups: One time testing - able-bodied healthy adults, Usual Care, then Cognitive Multisensory Therapy - adults with spinal cord injury + neuropathic pain., Cognitive Multisensory Therapy, then Usual Care - adults with spinal cord injury + neuropathic pain.
Neuropathic Pain Clinical Trial 2023: Cognitive Multisensory Rehabilitation Highlights & Side Effects. Trial Name: NCT04706208 — N/A
Cognitive Multisensory Rehabilitation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04706208 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What key aims are being explored in this research endeavor?

"This trial evaluates the efficacy of treatment approaches, assessing progress at baseline, mid-evaluation (12 weeks), and final evaluation (24 weeks) via Pain Numeric Rating Scale from International SCI Basic Pain Data Set. Participants will also be asked to complete Physical Activity Recall Questionnaire (~10 minutes), Spielberger State-Trait Anxiety Inventory (~5 minutes), and Patient Health Questionnaire PHQ-9(~3 minutes). The latter assesses depression symptoms on a scale of 0-27 with higher scores correlating with more severe cases. Additionally, there is one question that gauges how difficult problems have made it for patients to do"

Answered by AI

To what demographic is enrollment for this clinical trial open?

"Qualifying participants must have a spinal cord injury and be between 18-70 years of age in order to join this clinical trial. A maximum of 90 people are being accepted into the study."

Answered by AI

Are new participants being accepted at this time for the experiment?

"Affirmative. Clinicaltrials.gov confirms that this ongoing research project was initially posted on the 1st of September in 2020 and is still recruiting participants, with 90 individuals required from a single location. The page has been updated as recently as January 27th 2022."

Answered by AI

What is the maximum age for participation in this experiment?

"The age requirements for this medical trial necessitate that prospective patients must be over 18 years of age, yet under 70."

Answered by AI

How many participants are being recruited for this trial?

"Affirmative. Clinicaltrials.gov discloses that this examination is at present recruiting patients. It was first posted on September 1st 2020 and amended most recently on January 27th 2022, with an aim to recruit 90 individuals from a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Identifying Body Awareness-related Brain Network Changes During Cognitive Multisensory Rehabilitation for Reduced Neuropathic Pain in People With Spinal Cord Injury
2020. "Identifying Body Awareness-related Brain Network Changes During Cognitive Multisensory Rehabilitation for Reduced Neuropathic Pain in People With Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04706208.
~13 spots leftby Apr 2025
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