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Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord will be a safe and effective treatment for CIPN, reducing pain in the lower extremities by at least 50%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group - SCS | Experimental | Patients who are eligible will receive a trial implant for a 3-7 day trial period. If there is at least 50% pain relief in the trial period, the patients will receive the permanent SCS implant and will be followed for 1 year post permanent implant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation Implant | Device | Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord |
|
| Measure | Description | Time Frame |
|---|---|---|
| -- Measure response of CIPN pain to HF10 treatment using the numeric scale of pain (NRS) at SCS trial for all subjects and at 3, 6 and 12 months after implant for subjects who qualify for permanent implant. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| - - Neuropathy symptoms will be quantified using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (CIPN20). CIPN20 is a 20-item patient questionnaire with items scored 1 to 4. | CIPN20 is a 20-item patient questionnaire with items scored 1 to 4. Scores vary from 20 to 80, with higher scores indicating more prevalent neuropathy symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aja Janyavula, MD, MPH | Contact | 4104275459 | UMSJMCtrials@umm.edu |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| 1 year |
| - Pain interference in daily life will be quantified via the brief pain inventory (BPI). | BPI includes reported pain severity (NRS) and a 7-item questionnaire assessing pain interference with each item scored 0-10 with higher scores indicating worsened pain interference. | 1 year |
| - Neuropathy findings will be quantified with the modified Toronto clinical neuropathy score (mTCNS). | The mTCNS is a clinician administered exam with 11 items scored 0-3. A normal score is 0 with higher scores indicating worsened neuropathy on physical exam, up to a maximum of 33. | 1 year |
| - The subject's impression of SCS efficacy will be measured using the patient global impression of change (PGIC). | PGIC is a 7 point scale rating their impression (1-"very much improved", 2-"much improved", 3-"minimally improved", 4-"no change", 5-"minimally worse", 6-"much worse", 7-"very much worse"). | 1 year |
| - Health related quality of life will be assessed using the EuroQOL5D-5L questionnaire. | 1 year |
| - Any treatment related adverse events observed during the trial will be documented using the Common Terminology Criteria for Adverse Events (CTCAE) ver 5.0. | 1 year |