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| Name | Class |
|---|---|
| University of Surrey | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Brain activity | Change in brain activity, as measured by Blood Oxygen Level Dependent (BOLD) signal | Immediately post-training session (1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Intensity of pain rated on a 0-10 Numeric Rating Scale ranging from 0 = no pain to 10 = worst pain imaginable | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeanne M. Zanca, PhD, MPT | Contact | 973-324-3558 | jzanca@kesslerfoundation.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | Recruiting | West Orange | New Jersey | 07052 | United States |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 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. | Immediately post-training session (1 day) |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |