Back to resultsUtility of Multisensory Body-Representation in Spinal Cord Injury (SCI) With Pain
Primary Purpose
Spinal Cord Injuries, Neuropathic Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS and bodily illusions
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility Criteria
The study will be open to people of any ethnicity, racial background, and gender. Inclusion criteria: SCI with Pain: Men or women fluent in English 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: Major psychiatric disease/disorder (self-reported); a significant neurological trauma (self-reported) other than SCI; a recent (one-year) history of alcohol or drug abuse assessed by the Drug Abuse Screening Test (DAST-10) history of visual and hearing loss not corrected history of epilepsy or seizures 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
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SCI with pain
Arm Description
Participants will undergo 2-4 weeks of combined intervention including transcranial direct current stimulation (tDCS) and bodily illusions (10 sessions total).
Outcomes
Primary Outcome Measures
Change in neuropathic pain severity assessed by Neuropathic Pain Symptom Inventory (NPSI)
The NPSI is a self-reported, validated questionnaire that includes 10 items (on different pain sensations, e.g., burning, squeezing, electric-shock, etc.) used to evaluate the properties of neuropathic pain. Each item is scored on an 11-point NRS (0 meaning no symptom and 10 meaning worst symptom), with higher scores indicating more severe neuropathic pain symptoms.
Change in neuropathic pain interference assessed by pain interference questionnaire.
The questionnaire consists in a numerical rating of pain interference ranging from 0= No Interference to 10=Extreme interference with activities, mood and sleep
Changes associated with sensory function/dysfunction assessed by quantitative sensory testing
The sensory test assesses thermal thresholds and includes:
cool detection threshold (CDT), warm detection threshold (WDT), cold pain threshold (CPT), hot pain threshold (HPT), all performed using the method of limits: 0 to 50 Celsius (ºC) all values will be reported in Celsius.
Secondary Outcome Measures
Change in manageable pain assessed by days of manageable pain questionnaire.
This item specifies the total number of days with pain during the last 7 days, including today, and the response categories ranges from 0=none to 7=seven days.
Changes of psychosocial assessed by Multidimensional Pain Inventory (pain severity subscale)
Multidimensional Pain Inventory assesses the psychosocial impact of pain. This scale consists of three questions: 1) pain at the present moment; 2) pain during the past week and 3) suffering because of pain.
The range of the responses are from 0 (no pain or suffering) to 6 (extreme pain or suffering) and the scores of these three questions will be summed to obtain a composite pain severity score.
Change in Global impression of changes by PGIC questionnaire
Patients' Global Impression of Changes (PGIC) assesses patients' perceptions of changes following treatment. It is a 7-point verbal scale, with the options ranging from "very much improved" (3), "much improved" (2), "minimally improved" (1), "no change" (0), "minimally worsened" (-1) "much worsened" (-2), and "very much worsened" (-3).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06010251
Brief Title
Utility of Multisensory Body-Representation in Spinal Cord Injury (SCI) With Pain
Official Title
Mechanisms and Utility of Multisensory Body- Representation in SCI and SCI-Related Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 20, 2023 (Anticipated)
Primary Completion Date
October 20, 2026 (Anticipated)
Study Completion Date
October 20, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SCI with pain
Arm Type
Experimental
Arm Description
Participants will undergo 2-4 weeks of combined intervention including transcranial direct current stimulation (tDCS) and bodily illusions (10 sessions total).
Intervention Type
Other
Intervention Name(s)
tDCS and bodily illusions
Intervention Description
Participants will be required to perform (in person) 10 interventions over a time frame of 2-4 weeks. They can perform this everyday or for a minimum of 2-3 times per week over 4 weeks.
Two types of illusions will be used 15 min each, the rubber hand illusion and the walking illusion to target upper and lower limbs. These procedures will impact the body representation of the participants resulting in bodily illusions.
Primary Outcome Measure Information:
Title
Change in neuropathic pain severity assessed by Neuropathic Pain Symptom Inventory (NPSI)
Description
The NPSI is a self-reported, validated questionnaire that includes 10 items (on different pain sensations, e.g., burning, squeezing, electric-shock, etc.) used to evaluate the properties of neuropathic pain. Each item is scored on an 11-point NRS (0 meaning no symptom and 10 meaning worst symptom), with higher scores indicating more severe neuropathic pain symptoms.
Time Frame
Baseline, up to 4 weeks
Title
Change in neuropathic pain interference assessed by pain interference questionnaire.
Description
The questionnaire consists in a numerical rating of pain interference ranging from 0= No Interference to 10=Extreme interference with activities, mood and sleep
Time Frame
Baseline, up to 4 weeks
Title
Changes associated with sensory function/dysfunction assessed by quantitative sensory testing
Description
The sensory test assesses thermal thresholds and includes:
cool detection threshold (CDT), warm detection threshold (WDT), cold pain threshold (CPT), hot pain threshold (HPT), all performed using the method of limits: 0 to 50 Celsius (ºC) all values will be reported in Celsius.
Time Frame
Baseline, up to 4 weeks
Secondary Outcome Measure Information:
Title
Change in manageable pain assessed by days of manageable pain questionnaire.
Description
This item specifies the total number of days with pain during the last 7 days, including today, and the response categories ranges from 0=none to 7=seven days.
Time Frame
Baseline, up to 4 weeks
Title
Changes of psychosocial assessed by Multidimensional Pain Inventory (pain severity subscale)
Description
Multidimensional Pain Inventory assesses the psychosocial impact of pain. This scale consists of three questions: 1) pain at the present moment; 2) pain during the past week and 3) suffering because of pain.
The range of the responses are from 0 (no pain or suffering) to 6 (extreme pain or suffering) and the scores of these three questions will be summed to obtain a composite pain severity score.
Time Frame
Baseline, up to 4 weeks
Title
Change in Global impression of changes by PGIC questionnaire
Description
Patients' Global Impression of Changes (PGIC) assesses patients' perceptions of changes following treatment. It is a 7-point verbal scale, with the options ranging from "very much improved" (3), "much improved" (2), "minimally improved" (1), "no change" (0), "minimally worsened" (-1) "much worsened" (-2), and "very much worsened" (-3).
Time Frame
Baseline, up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The study will be open to people of any ethnicity, racial background, and gender.
Inclusion criteria:
SCI with Pain:
Men or women
fluent in English
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:
Major psychiatric disease/disorder (self-reported);
a significant neurological trauma (self-reported) other than SCI;
a recent (one-year) history of alcohol or drug abuse assessed by the Drug Abuse Screening Test (DAST-10)
history of visual and hearing loss not corrected
history of epilepsy or seizures
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Widerstrom-Noga, PhD
Phone
(305)243-7125
Email
ewiderstrom-noga@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta Vastano, PhD
Phone
754 207 3627
Email
rxv331@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Widerstrom-Noga, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Widerstrom-Noga, PhD
Phone
305-243-7125
Email
ewiderstrom-noga@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Roberta Vastano, PhD
Phone
7542073627
Email
rxv331@miami.edu
First Name & Middle Initial & Last Name & Degree
Eva Widerstrom-Noga, PhD
First Name & Middle Initial & Last Name & Degree
Roberta Vastano, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Utility of Multisensory Body-Representation in Spinal Cord Injury (SCI) With Pain
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