Neuropathic PainEarly Phase 1NCT04386174
Brain Activity in People With Chronic Neuropathic Pain and Spinal Cord Injury
A Early Phase 1 study testing Neurofeedback in people with Neuropathic Pain and Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Spinal Cord Injury
- What is being tested?
- Neurofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to Jul 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Jeanne M Zanca, PhD, MPT, 973-324-3558, jzanca@kesslerfoundation.org
Jeanne M Zanca, PhD, MPT
About this study
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.
Read the 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.
- Conditions
- Neuropathic Pain, Spinal Cord Injury
- Being tested
- Neurofeedback
- Medical subject headings
- Neuralgia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity
Change in brain activity, as measured by Blood Oxygen Level Dependent (BOLD) signal
Measured: Immediately post-training session (1 day)
Secondary outcomes (3)
Pain Intensity
Intensity of pain rated on a 0-10 Numeric Rating Scale ranging from 0 = no pain to 10 = worst pain imaginable
Measured: Immediately post-training session (1 day)
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
Measured: Immediately post-training session (1 day)
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.
Measured: Immediately post-training session (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Aug 2020
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Surrey
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386174
- Sponsor's protocol ID
- R-1057-19
- Status last verified
- Nov 2021
- First submitted
- 8 May 2020
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Activity in People With Chronic Neuropathic Pain and Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04386174
- Acronym / sponsor ID
- R-1057-19
- Conditions
- Neuropathic Pain, Spinal Cord Injury
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- University of Surrey
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Other: NeurofeedbackParticipants 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. |
| Group B | Other | Other: NeurofeedbackParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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")
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackInformation 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. | Other | Group A, Group B |
Primary outcome
Brain activity
Time frame: Immediately post-training session (1 day)
Change in brain activity, as measured by Blood Oxygen Level Dependent (BOLD) signal
3 secondary outcomes
Pain Intensity
Time frame: Immediately post-training session (1 day)
Pain Unpleasantness
Time frame: Immediately post-training session (1 day)
Exit Interview
Time frame: Immediately post-training session (1 day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Neurofeedback in people with Neuropathic Pain and Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeanne M. Zanca, PhD, MPT (973-324-3558, jzanca@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity (time frame: Immediately post-training session (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2021.