Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO)

Neuralgia Clinical Trial

— ECHO  

Official title:

Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO). An Open, Prospective, Multicenter Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386058
• Other study ID #: SCS ECHO
• Status: Completed
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: November 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Spinal cord stimulation is a minimally invasive surgical treatment for severe, chronic, neuropathic pain that is refractory to conventional treatment.

The treatment consists of an electrode implanted in the epidural space of the spinal cord, either via a percutaneous approach (using the so-called percutaneous leads) or via a surgical (hemi-) laminectomy (using the so-called surgical leads or plate leads).

It is a well-known clinical observation that when activating or deactivating SCS stimulation, there is a variable interval before the patient perceives a clinical effect of the change. This variation goes by different names (carryover, echo, after effect, etc.) and might be dependent on the clinical condition and treatment duration. To our knowledge only very little research has been published on the topic of carryover effects; a recent study showed that the interval is highly variable between patients.

While patients may experience immediate pain relief at the onset of SCS treatment, the effect in patients with a long-term SCS treatment history may have different characteristics, possibly due to ongoing changes in the nervous system.

The aim of this pilot study is to lay the foundation for investigating the carryover effects in spinal cord stimulation.

This will be carried out in a mixed population of patients with different indications for SCS, and with different treatment durations.

Patients will be asked to deactivate their device via their remote control or with a magnet in a standardized fashion.

They will be asked to reactivate the device when specific parameters have been met, and the time is recorded.

Description:

In the post-hoc analysis the carryover and reverse carryover effect will be analyzed and correlated to a number of parameters including, but not limited to: Indication, treatment duration, symptom duration, preoperative pain score, stimulation paradigm, gender, age.

Data will be collected and stored using a dedicated REDCap database under the auspices of Aarhus University.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient age minimum 18 years

• signed informed consent

• implanted with full SCS system for neuropathic pain

• SCS treatment duration minimum 6 months before inclusion

• maximum pain score 7 or less on a 0-10 NRS at the area of pain treated with SCS during the last 48 hours before study-related deactivation of the device

Exclusion Criteria

• any surgical SCS lead revision for the last 6 months before inclusion

• any changes in the programming patterns of the device (except patient-controlled changes in amplitude) for a minimum of 30 days before the study-related deactivation of the device

• any other ongoing neuromodulatory treatment (PNS, TENS, etc.)

• any other neuromodulatory treatment with lasting effect (RFA, sympathectomy, infiltration anesthesia, nerve blockade) within the last 60 days

• any changes in analgetic medication within the last 30 days (pn. dosings are allowed)

Related Conditions & MeSH terms

• Neuralgia
• Spinal Cord Stimulation

Intervention

Device:
• Temporary device deactivation
Patient-controlled, temporary deactivation of implanted device

Locations

Country	Name	City	State
Belgium	AZ Delta Roeselare/Menen/Torhout	Roeselare
Canada	CHU de Québec - Université Laval	Quebec City	Quebec
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Odense University Hospital	Odense
Germany	Diakovera Friederikenstift	Hannover
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel
Netherlands	Erasmus University Medical Center	Rotterdam
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Sunderby Hospital	Luleå

Sponsors (11)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg University Hospital, Aarhus University Hospital, AZ Delta, CHU de Quebec-Universite Laval, Diakoniekrankenhaus Friederikenstift, Erasmus Medical Center, Medisch Spectrum Twente, Odense University Hospital, Sahlgrenska University Hospital, Sweden, Sunderby Hospital

Countries where clinical trial is conducted

Belgium,  Canada,  Denmark,  Germany,  Netherlands,  Sweden, 

References & Publications (2)

Perruchoud C, Eldabe S, Batterham AM, Madzinga G, Brookes M, Durrer A, Rosato M, Bovet N, West S, Bovy M, Rutschmann B, Gulve A, Garner F, Buchser E. Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study. Neuromodulation. 2013 Jul-Aug;16(4):363-9; discussion 369. doi: 10.1111/ner.12027. Epub 2013 Feb 20. — View Citation

Wolter T, Winkelmüller M. Continuous versus intermittent spinal cord stimulation: an analysis of factors influencing clinical efficacy. Neuromodulation. 2012 Jan-Feb;15(1):13-9; discussion 20. doi: 10.1111/j.1525-1403.2011.00410.x. Epub 2011 Dec 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carryover/echo effect: Time from deactivation of device to cessation of treatment affect	Time from deactivation of device to cessation of treatment affect	Up to one week (may be repeated)
Secondary	Reverse carryover/echo effect: Time from reactivation of device to full reestablishment of treatment effect	Time from reactivation of device to full reestablishment of treatment effect	Up to one week (may be repeated)