Coordinated Reset Spinal Cord Stimulation

NCT04997278 | Withdrawn FDA Device

• 1 other identifier: 44884
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

spinal cord stimulation; chronic pain; neuropathic pain; failed back surgery syndrome

Outcome Measures

Primary Outcomes (1)

• Pain relief

  Difference in mean reduction in visual analog scale (VAS) score between sSCS and CR-SCS for leg pain and / or back pain compared to baseline, with 0 indicating no pain and 100 indicating worst pain.

  One month

Secondary Outcomes (5)

• Activity level

  One month

• Oswestry Disability Index, Sort Form-12

  One month

• Global Assessment of functioning Scale (GAF)

  One month

• Electroencephalography (EEG)

  One month

• Event Related Potentials (ERP)

  One month

Study Arms (1)

Coordinated Reset- Spinal Cord Stimulation

EXPERIMENTAL

All subjects will undergo spinal cord stimulation (SCS) implantation and will be optimized on standard SCS (sSCS) settings using the standard clinical protocol, including paresthesia mapping, threshold finding, and adjustment of stimulation parameters to provide reduction in pain. Therapeutic sSCS will be maintained for a minimum of one month prior to baseline assessment. Following a washout period of three hours assessments will be performed and Coordinated Reset- spinal cord stimulation (CR-SCS) will be enabled by means of a firmware upgrade. Personnel from Boston Scientific will perform this upgrade. The simulator will then be programmed to deliver CR-SCS. At the end of one month of CR-SCS (with stimulation parameters similarly held constant for the last 7 days), baseline assessment will be repeated after a three hour washout period. Finally, a firmware downgrade will be performed by Boston Scientific Personnel, and patients will be treated with sSCS at their previous settings.

Device: Coordinated Reset spinal cord stimulation

Interventions

Coordinated Reset spinal cord stimulation DEVICE

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).

Coordinated Reset- Spinal Cord Stimulation

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic neuropathic lower extremity pain, without back pain, who have consented to undergo or are undergoing spinal cord stimulation (SCS)
• Age 22 to 70
• Fluent in English and able to independently provide consent
• Patients treated with conventional SCS for at least 3 months prior to commencement of study, either newly implanted or already implanted.
• Patients have pronounced pain, i.e. visual analog scale score (VAS) ≥6 and respond to conventional SCS, i.e. VAS reduction of at least 50% with SCS.

You may not qualify if:

• Significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
• Current drug or alcohol abuse as determined by the investigator.
• Any history of recurrent or unprovoked seizures.
• Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \<12 months.
• Females who are pregnant, breastfeeding, or are of childbearing potential and planning to get pregnant during the course of the study or not using adequate contraception
• On anticoagulation therapy

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Neuralgia; Failed Back Surgery Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Back Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosurgery

Model Details: A single group will be studied, comparing the new stimulation paradigm with the standard paradigm

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 9, 2021
• Study Start: July 12, 2021
• Primary Completion: September 5, 2023
• Study Completion: September 5, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)