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NCT Number: NCT06596200

Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy

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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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Failure of medical therapy, which must have included duloxetine
  • Age 18 or greater

Exclusion criteria

  • 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
  • Receipt of vincristine, thalidomide, bortezomib, or eribulin within the prior 12 months

Treatment and study plan

Spinal Cord Stimulation Implant

Device

Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord

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 year

Secondary 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.

    Time frame: 1 year

    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.

  2. - Pain interference in daily life will be quantified via the brief pain inventory (BPI).

    Time frame: 1 year

    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.

  3. - Neuropathy findings will be quantified with the modified Toronto clinical neuropathy score (mTCNS).

    Time frame: 1 year

    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.

  4. - The subject's impression of SCS efficacy will be measured using the patient global impression of change (PGIC).

    Time frame: 1 year

    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").

  5. - Health related quality of life will be assessed using the EuroQOL5D-5L questionnaire.

    Time frame: 1 year

  6. - Any treatment related adverse events observed during the trial will be documented using the Common Terminology Criteria for Adverse Events (CTCAE) ver 5.0.

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Aja Janyavula, MD, MPH

CONTACT

[email protected]

4104275459

Sponsors and collaborators

Lead sponsor

University of Maryland St. Joseph Medical Center

Other

Registry information

Official study title

Pilot Study for the Use of Spinal Cord Stimulation to Alleviate Pain from Chemotherapy Induced Peripheral Neuropathy Due to Taxane or Platinum Based Agents

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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