Brain Activity in People With Chronic Neuropathic Pain and Spinal Cord Injury

NCT04386174 | Unknown Early Phase 1

• 1 other identifier: R-1057-19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Brain activity

  Change in brain activity, as measured by Blood Oxygen Level Dependent (BOLD) signal

  Immediately post-training session (1 day)

Secondary Outcomes (3)

• Pain Intensity

  Immediately post-training session (1 day)

• Pain Unpleasantness

  Immediately post-training session (1 day)

• Exit Interview

  Immediately post-training session (1 day)

Study Arms (2)

Group A

OTHER

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.

Other: Neurofeedback

Group B

OTHER

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.

Other: Neurofeedback

Interventions

Neurofeedback OTHER

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.

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead
• University of Surrey: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Central Study Contacts

Jeanne M. Zanca, PhD, MPT

CONTACT

973-324-3558; jzanca@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 13, 2020
• Study Start: August 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)