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Evaluation of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy for Treatment of Chemotherapy Induced Peripheral Neuropathy

NCT ID: NCT07304401

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-12-01

Brief Summary

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The goal of this observational study is to learn about the effectiveness of closed-loop spinal cord stimulation (CL-SCS) therapy for treatment of painful chemotherapy induced peripheral neuropathy.

The closed-loop SCS (CL-SCS) system stimulates the nerves in the spinal cord, measures their responses and automatically adjust the stimulation level accordingly in real time for each delivered pulse.

Detailed Description

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Chemotherapy induced peripheral neuropathy (CIPN) is a serious condition that is diagnosed in up to 40% of patients who require chemotherapy. Conventional treatments for painful CIPN include both pharmacological and non-pharmacological interventions, although the underlying evidence is scarce. Spinal cord stimulation is an established treatment for pain associated with painful peripheral neuropathies. Several studies demonstrate pain relief by open-loop spinal cord stimulation (SCS) in patients with painful CIPN, with a positive effect of SCS on pain and quality of life. In the Netherlands, CIPN is an accepted indication for SCS treatment and thus SCS is a regular treatment for patients with painful and refractory CIPN. The closed-loop SCS (CL-SCS) system stimulates the dorsal column in the spinal cord, measures the response through evoked compound action potentials (ECAPs), and automatically adjust the stimulation level accordingly in real time for each delivered pulse.

The current study aims to evaluate the effectiveness of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with CIPN.

Conditions

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Chemotherapy Induced Peripheral Neuropathy (CIPN) Neuropathic Pain

Keywords

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CIPN Chemotherapy induced peripheral neuropathy Spinal Cord Stimulation SCS Closed-Loop neuropathic pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with painful chemotherapy induced peripheral neuropathy (CIPN)

Subjects diagnosed with painful CIPN and eligible for SCS implantation

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

* Patient refusal to be included in study
* Patients unwilling or mentally incapable to complete the study questionnaires
* Other causes of neuropathy (for example diabetic- or small fiber neuropathy)
* Previous treatment with SCS for CIPN
* Presence of another pain syndrome unrelated to CIPN
* History of lower limb amputation or ulceration
* Body mass index (BMI) ≥ 40
* Severe psychiatric or neurological disorders
* Any other contra indication for locoregional anaesthesia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saluda Medical Pty Ltd

INDUSTRY

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rijnstate Hospital

Arnhem, , Netherlands

Site Status RECRUITING

Sint Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status RECRUITING

Bravis Hospital

Roosendaal, , Netherlands

Site Status RECRUITING

ETZ

Tilburg, , Netherlands

Site Status RECRUITING

ASZ

Zwijndrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Esmee Van Leeuwen, MSc

Role: CONTACT

Phone: 088 005 8888

Email: [email protected]

Nick Koning, MD PhD

Role: CONTACT

Facility Contacts

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Esmee Van Leeuwen, MSc

Role: primary

Role: backup

Harold Nijhuis, MD

Role: primary

Lars Elzinga, MD

Role: primary

Johan van de Minkelis, MD

Role: primary

Hans Aukes, MD

Role: primary

Other Identifiers

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2025-2667

Identifier Type: -

Identifier Source: org_study_id