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| ID | Type | Description | Link |
|---|---|---|---|
| SC220073 | Other Grant/Funding Number | CDMRP |
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The purpose of this study is to investigate the effectiveness of bodily illusions combined with transcranial direct current stimulation (tDCS) on neuropathic pain symptoms and sensory functions in participants with spinal cord injury (SCI) and neuropathic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCI with pain | Experimental | Participants will undergo 2-4 weeks of combined intervention including transcranial direct current stimulation (tDCS) and bodily illusions (10 sessions total). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS and bodily illusions | Other | Participants will be required to perform (in person) 10 interventions over a time frame of 2-4 weeks. They can perform this everyday or for a minimum of 2-3 times per week over 4 weeks. Two types of illusions will be used 15 min each, the rubber hand illusion and the walking illusion to target upper and lower limbs. These procedures will impact the body representation of the participants resulting in bodily illusions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in neuropathic pain severity assessed by Neuropathic Pain Symptom Inventory (NPSI) | The NPSI is a self-reported, validated questionnaire that includes 10 items (on different pain sensations, e.g., burning, squeezing, electric-shock, etc.) used to evaluate the properties of neuropathic pain. Each item is scored on an 11-point NRS (0 meaning no symptom and 10 meaning worst symptom), with higher scores indicating more severe neuropathic pain symptoms. | Baseline, up to 4 weeks |
| Change in neuropathic pain interference assessed by pain interference questionnaire. | The questionnaire consists in a numerical rating of pain interference ranging from 0= No Interference to 10=Extreme interference with activities, mood and sleep | Baseline, up to 4 weeks |
| Changes associated with sensory function/dysfunction assessed by quantitative sensory testing | The sensory test assesses thermal thresholds and includes: cool detection threshold (CDT), warm detection threshold (WDT), cold pain threshold (CPT), hot pain threshold (HPT), all performed using the method of limits: 0 to 50 Celsius (ºC) all values will be reported in Celsius. | Baseline, up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in manageable pain assessed by days of manageable pain questionnaire. | This item specifies the total number of days with pain during the last 7 days, including today, and the response categories ranges from 0=none to 7=seven days. | Baseline, up to 4 weeks |
| Changes of psychosocial assessed by Multidimensional Pain Inventory (pain severity subscale) |
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The study will be open to people of any ethnicity, racial background, and gender.
Inclusion criteria:
SCI with Pain:
Exclusion criteria:
Participants will be excluded if they have:
We will not include any special population like:
Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Widerstrom-Noga, PhD | Contact | (305)243-7125 | ewiderstrom-noga@med.miami.edu | |
| Roberta Vastano, PhD | Contact | 754 207 3627 | rxv331@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eva Widerstrom-Noga, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Multidimensional Pain Inventory assesses the psychosocial impact of pain. This scale consists of three questions: 1) pain at the present moment; 2) pain during the past week and 3) suffering because of pain. The range of the responses are from 0 (no pain or suffering) to 6 (extreme pain or suffering) and the scores of these three questions will be summed to obtain a composite pain severity score. |
| Baseline, up to 4 weeks |
| Change in Global impression of changes by PGIC questionnaire | Patients' Global Impression of Changes (PGIC) assesses patients' perceptions of changes following treatment. It is a 7-point verbal scale, with the options ranging from "very much improved" (3), "much improved" (2), "minimally improved" (1), "no change" (0), "minimally worsened" (-1) "much worsened" (-2), and "very much worsened" (-3). | Baseline, up to 4 weeks |
| D014947 | Wounds and Injuries |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |