Brain Activity in People With Chronic Neuropathic Pain and Spinal Cord Injury
Primary Purpose
Neuropathic Pain, Spinal Cord Injury
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Neurofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain
Eligibility Criteria
Inclusion Criteria:
- Age 18 or over
- Right-handed
- Complete or incomplete chronic (>1 year) SCI classified as having a neurological level of C4 or below
- Chronic (≥3 month history) at- or below-level neuropathic pain
- Neuropathic pain of moderate or greater intensity (average intensity over the last week of ≥4 on an 11-point Numeric Rating Scale (NRS), where 0 = "no pain" and 10 = "worst pain imaginable")
- Neuropathic pain that is constant (present 7 days/week, 24 hours/day)
- Using a stable pain treatment regimen (not actively in process of starting a new pain treatment or changing dosage of an existing treatment)
- Able to understand verbal and written English
- Able and willing to comply with the study protocol, including availability for scheduled study procedures
Exclusion Criteria:
- Current non-neuropathic pain of severe intensity (average intensity over the last week of ≥7 on an 11-point NRS, where 0 = "no pain" and 10 = "worst pain imaginable")
- SCI due to malignancy
- Cognitive impairment that could interfere with learning (Mini-Mental State Exam score of <24)
- Current sacral, coccyx, or heel pressure injury
- Claustrophobia or fear of confined spaces
- Presence of any non-MRI compatible material in the body such as pacemakers or other implanted electrical devices, brain stimulators, particular types of dental implants, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids [cochlear implants]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments
- If female, currently pregnant
- Required use of non-MRI-compatible orthoses or devices (braces, ventilators, etc.)
- Current or past history of work as a welder or metal worker (because of possible small metal fragments in the eye of which they may be unaware)
- Inability to tolerate a supine position
- History (via self-report) of significant, uncontrollable spasticity while lying in supine position
- Progressive conditions that impact physical or cognitive functioning (metastatic cancer, multiple sclerosis, Parkinson Disease, Alzheimer's disease, etc.)
- History of traumatic brain injury
- Diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder
- History of substance abuse in the past six months
- Lack of intact sensation in the anterior shoulder (where stimuli will be applied during study procedures)
- Any other condition that would, in the opinion of the investigators, pose increased risk to the subject or affect the quality of data collected
Sites / Locations
- Kessler FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group A
Group B
Arm Description
Participants will be shown information about brain activity while trying different thinking strategies to change their experience of pain. Both groups will be shown brain activity, but the source of the brain activity information will differ between the groups.
Participants will be shown information about brain activity while trying different thinking strategies to change their experience of pain. Both groups will be shown brain activity, but the source of the brain activity information will differ between the groups.
Outcomes
Primary Outcome Measures
Brain activity
Change in brain activity, as measured by Blood Oxygen Level Dependent (BOLD) signal
Secondary Outcome Measures
Pain Intensity
Intensity of pain rated on a 0-10 Numeric Rating Scale ranging from 0 = no pain to 10 = worst pain imaginable
Pain Unpleasantness
Degree to which pain is unpleasant, rated on a 0-10 Numeric Rating Scale where 0 = not unpleasant at all to 10 = extremely unpleasant
Exit Interview
Participants will be asked questions in a semi-structured interview to learn about their experiences trying to use the information on brain activity to help them learn strategies to self-manage pain.
Full Information
NCT ID
NCT04386174
First Posted
May 8, 2020
Last Updated
November 11, 2021
Sponsor
Kessler Foundation
Collaborators
University of Surrey
1. Study Identification
Unique Protocol Identification Number
NCT04386174
Brief Title
Brain Activity in People With Chronic Neuropathic Pain and Spinal Cord Injury
Official Title
Brain Activity in People With Chronic Neuropathic Pain and Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
Collaborators
University of Surrey
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 research study is to learn more about how patterns of brain activity change during different thinking tasks and how these changes relate to the intensity and unpleasantness of the neuropathic pain that people with SCI experience.
Detailed Description
Neuropathic pain is a kind of pain that is caused by a disruption of the nervous system. Neuropathic pain is common among people with spinal cord injury (SCI), is often severe, and can interfere significantly with daily life. Current treatments do not eliminate neuropathic pain for most individuals. Therefore, it is important to identify other strategies that enable people with SCI to exert more control over their pain.
The purpose of this research study is to examine patterns of brain activity in people with SCI while they perform different thinking tasks. This study will help researchers understand how patterns of brain activity change during these tasks and how these tasks affect pain severity and unpleasantness. The information we learn in this study will help us create new treatment options to help people with SCI to manage their chronic neuropathic pain.
The study will take place over 2 days, separated by 1-3 weeks or so, depending on scheduling of study activities. The study should take approximately 1 hour on the first day (for a telephone interview), and up to 7.5 hours on the second day (for a visit to Kessler for functional magnetic resonance imaging, or fMRI).
In this study, participants will be asked to respond to a series of questions relating to their physical health, mental health, and pain history. The researchers may also review their medical records if needed to determine if it is safe for them to have an MRI. Those who qualify will visit Kessler and will be introduced to different thinking strategies that can be used to try to change the activity in the brain in areas that relate to the experience of pain. Participants will undergo 3 separate fMRI sessions. During the first session, the researchers will locate a pain-related region of the brain from which to gather information about brain activity. In the second and third sessions, the researchers will use fMRI to measure the activity in a pain-related region of the brain while the participant tries out different thinking strategies. While participants practice use of these strategies, they will be shown information about brain activity and will be asked to use this information as they try to become better at using the strategies. The researchers will also ask participants whether the experience of their pain (severity and unpleasantness) changed while they practiced these strategies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Other
Arm Description
Participants will be shown information about brain activity while trying different thinking strategies to change their experience of pain. Both groups will be shown brain activity, but the source of the brain activity information will differ between the groups.
Arm Title
Group B
Arm Type
Other
Arm Description
Participants will be shown information about brain activity while trying different thinking strategies to change their experience of pain. Both groups will be shown brain activity, but the source of the brain activity information will differ between the groups.
Intervention Type
Other
Intervention Name(s)
Neurofeedback
Intervention Description
Information about activity in pain-related regions of the brain will be shown to participants to determine if receiving this information is helpful in learning different thinking strategies (such as shifting attention, imagery, mantra meditation, etc.) that may help people with SCI change their experience of neuropathic pain.
Primary Outcome Measure Information:
Title
Brain activity
Description
Change in brain activity, as measured by Blood Oxygen Level Dependent (BOLD) signal
Time Frame
Immediately post-training session (1 day)
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Intensity of pain rated on a 0-10 Numeric Rating Scale ranging from 0 = no pain to 10 = worst pain imaginable
Time Frame
Immediately post-training session (1 day)
Title
Pain Unpleasantness
Description
Degree to which pain is unpleasant, rated on a 0-10 Numeric Rating Scale where 0 = not unpleasant at all to 10 = extremely unpleasant
Time Frame
Immediately post-training session (1 day)
Title
Exit Interview
Description
Participants will be asked questions in a semi-structured interview to learn about their experiences trying to use the information on brain activity to help them learn strategies to self-manage pain.
Time Frame
Immediately post-training session (1 day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or over
Right-handed
Complete or incomplete chronic (>1 year) SCI classified as having a neurological level of C4 or below
Chronic (≥3 month history) at- or below-level neuropathic pain
Neuropathic pain of moderate or greater intensity (average intensity over the last week of ≥4 on an 11-point Numeric Rating Scale (NRS), where 0 = "no pain" and 10 = "worst pain imaginable")
Neuropathic pain that is constant (present 7 days/week, 24 hours/day)
Using a stable pain treatment regimen (not actively in process of starting a new pain treatment or changing dosage of an existing treatment)
Able to understand verbal and written English
Able and willing to comply with the study protocol, including availability for scheduled study procedures
Exclusion Criteria:
Current non-neuropathic pain of severe intensity (average intensity over the last week of ≥7 on an 11-point NRS, where 0 = "no pain" and 10 = "worst pain imaginable")
SCI due to malignancy
Cognitive impairment that could interfere with learning (Mini-Mental State Exam score of <24)
Current sacral, coccyx, or heel pressure injury
Claustrophobia or fear of confined spaces
Presence of any non-MRI compatible material in the body such as pacemakers or other implanted electrical devices, brain stimulators, particular types of dental implants, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids [cochlear implants]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments
If female, currently pregnant
Required use of non-MRI-compatible orthoses or devices (braces, ventilators, etc.)
Current or past history of work as a welder or metal worker (because of possible small metal fragments in the eye of which they may be unaware)
Inability to tolerate a supine position
History (via self-report) of significant, uncontrollable spasticity while lying in supine position
Progressive conditions that impact physical or cognitive functioning (metastatic cancer, multiple sclerosis, Parkinson Disease, Alzheimer's disease, etc.)
History of traumatic brain injury
Diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder
History of substance abuse in the past six months
Lack of intact sensation in the anterior shoulder (where stimuli will be applied during study procedures)
Any other condition that would, in the opinion of the investigators, pose increased risk to the subject or affect the quality of data collected
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanne M. Zanca, PhD, MPT
Phone
973-324-3558
Email
jzanca@kesslerfoundation.org
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne M Zanca, PhD, MPT
Phone
973-324-3558
Email
jzanca@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Jeanne M Zanca, PhD, MPT
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brain Activity in People With Chronic Neuropathic Pain and Spinal Cord Injury
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