MedTrace Logo

Coordinated Reset Spinal Cord Stimulation

NCT04997278 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-09-08

No results posted yet for this study

Summary

The goal of this study is to evaluate whether a new spinal cord stimulation paradigm, called Coordinate Reset (CR) Stimulation, can provide equivalent or better pain relief with reduced energy requirements. The investigators will test this new stimulation paradigm in patients who are already undergoing spinal cord stimulation surgery. The investigators will also study whether there are changes in electroencephalography (brain waves) associated with this new stimulation paradigm.

The investigators hope to learn whether CR stimulation can provide equivalent or better pain relief with reduced energy requirements. They also hope to learn whether there are changes in brain function with effective CR stimulation compared to conventional stimulation.

This study will be testing a specific stimulation paradigm in people who have already consented to have spinal cord stimulation performed for treatment of their chronic pain.

Conditions

  • Pain, Neuropathic
  • Failed Back Surgery Syndrome

Interventions

DEVICE

Coordinated Reset spinal cord stimulation

Abnormal neuronal synchrony in terms of enhanced 4-9 Hz theta oscillations in EEG/MEG recordings appears to be an important pathophysiological finding in patients with neurogenic pain. To specifically counteract abnormal neuronal synchrony, we here set out to perform Coordinated Reset (CR)-Spinal Cord Stimulation (SCS). CR stimulation (Tass, 2003) aims at an anti-kindling, i.e. an "unlearning" or resetting of abnormal neuronal synchrony and abnormal synaptic connectivity, and, hence, long-lasting, sustained therapeutic effects that persist following cessation of stimulation (Tass \& Majtanik, 2006).

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2023-09-05
Completion
2023-09-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997278 on ClinicalTrials.gov