Recruiting
Early Phase 1

Observational Study

Sponsor:

Kessler Foundation

Code:

NCT04386174

Conditions

Neuropathic Pain

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neurofeedback

Study Details

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

Study ID

NCT04386174

Start date

Aug 1, 2020

Status verified date

Nov, 2021

Completion date

Jul, 2022

Anticipated

Primary completion date

Jul, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Group A

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: Group B

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.

Interventions

Neurofeedback

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

  • Brain activity [ Time Frame: Immediately post-training session (1 day) ]

Central Contacts and Locations

Central contacts

Jeanne M. Zanca, PhD, MPT

973-324-3558jzanca@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Jeanne M Zanca, PhD, MPT

973-324-3558jzanca@kesslerfoundation.org

Principal Investigator:

Jeanne M Zanca, PhD, MPT

More Information

Sponsor

Kessler Foundation

Last update posted

Nov 12, 2021

Last verified

Nov, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2021-11-12.