Pain, NeuropathicNCT04997278
Coordinated Reset Spinal Cord Stimulation
A study testing Coordinated Reset spinal cord stimulation in people with Pain, Neuropathic and Failed Back Surgery Syndrome, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Pain, Neuropathic, Failed Back Surgery Syndrome
- What is being tested?
- Coordinated Reset spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2021to 5 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Study subjects will be identified from the pool of candidates for spinal cord stimulation (SCS) therapy at Stanford University. Subjects will have undergone a successful trial of Boston Scientific spinal cord stimulation and will either be candidates for permanent stimulator implantation, or will have already undergone implantation. Ten subjects will be recruited over a one year period.
Following informed consent, subjects will be assessed to assure that they meet the criteria for study entry. All subjects will undergo 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.
Baseline assessments will be conducted following discontinuation of SCS for 24 hours. This assessment battery includes a physical and neurological exam, visual analog scale (VAS) score, Oswestry Disability Index, SF-12 and Global Assessment of Functioning, as well as EEG recordings (spontaneous EEG recording + dedicated pain-related evoked response recording). Following this baseline assessment, sSCS will be delivered for one month. Stimulation parameters will be held constant for the last 7 days of this period. During this time, subjects will use the CamNtech Pro-Diary wrist-worn data entry system to rate their back pain, leg pain and overall pain (3 questions), 3 times per day (morning, afternoon evening). The Pro-Diary allows for configurable, portable data entry as well as actigraphy.
The full assessment battery will be repeated, and the stimulator deactivated.
Following a washout period of three hours, VAS and EEG recordings will be performed. CR-SCS will be enabled by means of a firmware upgrade. Personnel from Boston Scientific will perform this upgrade. The stimulator 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), the assessment battery will be repeated, and VAS and EEG recordings will again be performed 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.
- Conditions
- Pain, Neuropathic, Failed Back Surgery Syndrome
- Being tested
- Coordinated Reset spinal cord stimulation
- Keywords
- spinal cord stimulation, chronic pain, neuropathic pain, failed back surgery syndrome
- Medical subject headings
- Neuralgia, Failed Back Surgery Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coordinated Reset spinal cord stimulationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Coordinated Reset spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month
Secondary outcomes (5)
Activity level
Use of CamNtech Pro-Diary wrist-worn data entry system to rate back pain, leg pain and overall pain (3 questions), 3 times per day (morning, afternoon evening). Patients will rate their pain on a 0-10 Visual Analog scale with 0 indicating no pain and 100 worst pain.
Measured: One month
Oswestry Disability Index, Sort Form-12
Oswestry Disability Index, Sort From-12 (also known as the Oswestry Low Back Pain Disability Questionnaire) is a 12 item short survey that measure a patient's permanent functional disability. Each section is scored on a 0-5 scale, 5 representing the greatest disability.
Measured: One month
Global Assessment of functioning Scale (GAF)
The Global Assessment of Functioning (GAF) scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect their day-to-day life on a scale of 0 to 100, with higher scores indicating that the subject is better at handling daily activities.
Measured: One month
Electroencephalography (EEG)
EEG activity will be quantified by means theta power (4-9 Hz), with decreases in theta power related to decreased pain. Theta power will be measured pre and post treatment.
Measured: One month
Event Related Potentials (ERP)
During the EEG, we will analyzed ERPs in response to each stimuli during stimulation. Changes in amplitude (micro-volts) will be analyzed pre and post treatment. ERP activity is exploratory.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start12 Jul 2021
- Primary completion5 Sep 2023
- Study completion5 Sep 2023
Why it stopped: Funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, NeuropathicStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group will be studied, comparing the new stimulation paradigm with the standard paradigm
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaimie M. Henderson, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997278
- Sponsor's protocol ID
- 44884
- Status last verified
- Sep 2023
- First submitted
- 12 Jul 2021
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD shared outside of Stanford
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinated Reset Spinal Cord Stimulation
- ClinicalTrials.gov ID
- NCT04997278
- Acronym / sponsor ID
- 44884
- Conditions
- Pain, Neuropathic, Failed Back Surgery Syndrome
- Keywords
- spinal cord stimulation, chronic pain, neuropathic pain, failed back surgery syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study subjects will be identified from the pool of candidates for spinal cord stimulation (SCS) therapy at Stanford University. Subjects will have undergone a successful trial of Boston Scientific spinal cord stimulation and will either be candidates for permanent stimulator implantation, or will have already undergone implantation. Ten subjects will be recruited over a one year period.
Following informed consent, subjects will be assessed to assure that they meet the criteria for study entry. All subjects will undergo 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.
Baseline assessments will be conducted following discontinuation of SCS for 24 hours. This assessment battery includes a physical and neurological exam, visual analog scale (VAS) score, Oswestry Disability Index, SF-12 and Global Assessment of Functioning, as well as EEG recordings (spontaneous EEG recording + dedicated pain-related evoked response recording). Following this baseline assessment, sSCS will be delivered for one month. Stimulation parameters will be held constant for the last 7 days of this period. During this time, subjects will use the CamNtech Pro-Diary wrist-worn data entry system to rate their back pain, leg pain and overall pain (3 questions), 3 times per day (morning, afternoon evening). The Pro-Diary allows for configurable, portable data entry as well as actigraphy.
The full assessment battery will be repeated, and the stimulator deactivated.
Following a washout period of three hours, VAS and EEG recordings will be performed. CR-SCS will be enabled by means of a firmware upgrade. Personnel from Boston Scientific will perform this upgrade. The stimulator 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), the assessment battery will be repeated, and VAS and EEG recordings will again be performed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group will be studied, comparing the new stimulation paradigm with the standard paradigm
| Arm | Type | Receives |
|---|---|---|
| Coordinated Reset- Spinal Cord Stimulation | Experimental | Device: Coordinated Reset spinal cord stimulationAll 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. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coordinated Reset spinal cord stimulationAbnormal 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). | Device | Coordinated Reset- Spinal Cord Stimulation |
Primary outcome
Pain relief
Time frame: One month
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.
5 secondary outcomes
Activity level
Time frame: One month
Oswestry Disability Index, Sort Form-12
Time frame: One month
Global Assessment of functioning Scale (GAF)
Time frame: One month
Electroencephalography (EEG)
Time frame: One month
Event Related Potentials (ERP)
Time frame: One month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No. No IPD shared outside of Stanford
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coordinated Reset spinal cord stimulation in people with Pain, Neuropathic and Failed Back Surgery Syndrome, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.