Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland St. Joseph Medical Center
About this trial
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%.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
CIPN as diagnosed by Oncology and/or neurology
Receipt of a platinum-based or taxane chemotherapy prior to development of CIPN
Pain severity greater than 4 out of 10 on a numeric rating scale of pain
Pain chronicity greater than 6 months after the cessation of chemotherapy
Disqualifiers
Platelet count less than 100k/mm3
Spinal anatomy precluding placement of the SCS leads between T6 and T11
Active infection
Estimated Lifespan less than 1 year
Trial design
Design model
Single group
Treatments tested in this trial
Spinal Cord Stimulation Implant
DeviceSpinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Intervention Group - SCSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
-- 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.
Time frame
1 yearSecondary outcomes
1
- - 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.
Time frame
1 year2
- 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.
Time frame
1 year3
- 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.
Time frame
1 year4
- 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").
Time frame
1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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