Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO) (ECHO)
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|ClinicalTrials.gov Identifier: NCT03386058|
Recruitment Status : Enrolling by invitation
First Posted : December 29, 2017
Last Update Posted : February 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Neuralgia Spinal Cord Stimulation||Device: Temporary device deactivation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open study|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO). An Open, Prospective, Multicenter Study.|
|Actual Study Start Date :||January 31, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Temporary device deactivation
Device: Temporary device deactivation
Patient-controlled, temporary deactivation of implanted device
- Carryover/echo effect: Time from deactivation of device to cessation of treatment affect [ Time Frame: Up to one week (may be repeated) ]Time from deactivation of device to cessation of treatment affect
- Reverse carryover/echo effect: Time from reactivation of device to full reestablishment of treatment effect [ Time Frame: Up to one week (may be repeated) ]Time from reactivation of device to full reestablishment of treatment effect
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386058
|Toronto Western Hospital, Department of Anesthesia and Pain Medicine|
|Toronto, Ontario, Canada, M5T 2S8|
|CHU de Québec - Université Laval|
|Quebec City, Quebec, Canada, G1J 1Z6|
|Aalborg University Hospital|
|Aalborg, Denmark, 9000|
|Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Odense University Hospital|
|Odense, Denmark, 5230|
|Hannover, Germany, 30169|
|Medisch Spectrum Twente|
|Enschede, Overijssel, Netherlands, 7512 KZ|
|Sahlgrenska University Hospital|
|Göteborg, Sweden, 413 45|
|Principal Investigator:||Kaare Meier, MD PhD||Aarhus University Hospital|