Spinal Cord StimulationNCT05283863
Direct Comparison of Spinal Cord Stimulator Parameter Settings
A study testing High-frequency stimulation in people with Spinal Cord Stimulation and High-frequency Stimulation, run by Case Western Reserve University at 1 site in United States.
Trial summary
(Primary) 1. To compare the clinical effects and side effects of two different stimulation strategies that do not produce any sensory percept (1000 Hz and placebo) on clinical benefit for electrodes implanted for chronic pain as measured by the Visual Analog Pain Scale for back and leg pain, the Brief Pain Inventory… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Stimulation, High-frequency Stimulation, High-density Stimulation
- What is being tested?
- High-frequency stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Diagnosis of chronic neuropathic pain for which placement of electrodes into the spinal column is planned for clinical indications (failed back surgery syndrome, peripheral neuropathy or complex regional pain syndrome)
- History of implantation of spinal cord stimulation system with rechargeable implanted neurostimulator
Who cannot join
- Significant dementia or other condition preventing informed consent by the patient.
- Current drug or alcohol abuse or dependence.
- Uncontrolled depression or anxiety or failure to pass psychological screening for spinal cord stimulation.
- Inability or unwillingness to cooperate with clinical testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44122
About this study
(Primary)
- To compare the clinical effects and side effects of two different stimulation strategies that do not produce any sensory percept (1000 Hz and placebo) on clinical benefit for electrodes implanted for chronic pain as measured by the Visual Analog Pain Scale for back and leg pain, the Brief Pain Inventory, the 36-Item Short Form Survey (SF-36), and the Pain Vigilance and Awareness Questionnaire. (Secondary)
- To compare the clinical effects of the subthreshold (paresthesia-free) stimulation patterns with conventional (paresthesia-producing) stimulation patterns to evaluate the necessity of paresthesias and current amplitudes on clinical benefit for pain.
- To identify the ability of subthreshold high-frequency to improve axial pain or the affective component of pain.
Read the detailed description
This is a prospective, randomized, double-blind study of different stimulation patterns in patients undergoing implantation of neurostimulator systems for chronic medically intractable neuropathic pain. Research participants will be individuals who have undergone implantation of neurostimulator electrodes into the spinal column or peripheral nervous system for clinical treatment of neuropathic pain. All patients will already have undergone empiric programming of the stimulator using conventional settings (typically 40-60 Hz, 350-450 usec pulse width). However, other stimulation parameters, including high-frequency stimulation, are also feasible and FDA-approved using the implanted device, and it is possible to do this without producing a sensory percept, which makes it possible to test efficacy in a double blind manner. For this study, two different stimulation parameters will be tested during four two-week periods: 1000 Hz and placebo. Clinical response and side effect profile for each setting will be measured.
- Being tested
- High-frequency stimulation, Sham Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency stimulationDevice
Patients in this group will receive sub-threshold high-frequency (aka 1200Hz) spinal cord stimulation for 2 weeks.
Sham StimulationDevice
Patients in this group will receive receive sham spinal cord stimulation (aka no stimulation) for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High-Frequency Stimulation, Then Placebo Stimulation | Experimental | Participants first receive sub-threshold high-frequency spinal cord stimulation (1200 Hz frequency, 200 μsec pulse width, and an amplitude 90% of the threshold for detection of a sensory percept) for 2 weeks. After a 2-week washout period, they then receive sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks. Receives: Device: High-frequency stimulation; Device: Sham Stimulation |
| Placebo Stimulation, Then High-Frequency Stimulation | Sham comparator | Participants first receive sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks. After a 2-week washout period, they then receive sub-threshold high-frequency spinal cord stimulation (1200 Hz frequency, 200 μsec pulse width, and an amplitude 90% of the threshold for detection of a sensory percept) for 2 weeks. Receives: Device: High-frequency stimulation; Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Scale
Assessment of overall degree of back and leg pain during each phase of stimulation (ie conventional baseline stimulation, high-density stimulation, conventional "washout" stimulation, and sham stimulation). Scores range from 0 - 100, with a higher score indicating more pain.
Measured: 8 weeks
Secondary outcomes (4)
Change in Brief Pain Inventory (BPI)
The BPI assesses pain at its "worst," "least," "average," and "now" (current pain). Each item is rated on a scale of 0 - 10 with 10 indicating higher levels of pain. For purposes of this outcome measure, we focused on "now" (current pain)
Measured: 8 weeks
Change in SF-36
The SF-36 is a measure of quality of life, with scores ranging from 0 - 100, with higher scores indicating a higher quality of life.
Measured: 8 weeks
Pain Vigilance and Awareness Questionnaire (PVAQ)
The PVAQ is a measure of vigilance and attention to pain. Total scores can range from 0 to 90, with higher scores indicating more pain vigilance.
Measured: 8 weeks
Number of Patients With Side Effects of Stimulation
Incidence of side effects of stimulation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study startJun 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord StimulationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- All subjects underwent two weeks of conventional stimulation, followed by randomization to receive either subthreshold high-density (HD) or sham stimulation; this was followed by a crossover during which the participants who had received subthreshold HD stimulation were treated with sham and vice versa.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer A Sweet, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283863
- Sponsor's protocol ID
- 10-13-29
- Status last verified
- May 2024
- First submitted
- 23 Dec 2021
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sweet J, Badjatiya A, Tan D, Miller J. Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series. Neuromodulation. 2016 Apr;19(3):260-7. doi: 10.1111/ner.12357. Epub 2015 Oct 20.
PubMed 26481726
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Comparison of Spinal Cord Stimulator Parameter Settings
- ClinicalTrials.gov ID
- NCT05283863
- Acronym / sponsor ID
- 10-13-29
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Posted 21 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(Primary)
- To compare the clinical effects and side effects of two different stimulation strategies that do not produce any sensory percept (1000 Hz and placebo) on clinical benefit for electrodes implanted for chronic pain as measured by the Visual Analog Pain Scale for back and leg pain, the Brief Pain Inventory, the 36-Item Short Form Survey (SF-36), and the Pain Vigilance and Awareness Questionnaire. (Secondary)
- To compare the clinical effects of the subthreshold (paresthesia-free) stimulation patterns with conventional (paresthesia-producing) stimulation patterns to evaluate the necessity of paresthesias and current amplitudes on clinical benefit for pain.
- To identify the ability of subthreshold high-frequency to improve axial pain or the affective component of pain.
Detailed description
This is a prospective, randomized, double-blind study of different stimulation patterns in patients undergoing implantation of neurostimulator systems for chronic medically intractable neuropathic pain. Research participants will be individuals who have undergone implantation of neurostimulator electrodes into the spinal column or peripheral nervous system for clinical treatment of neuropathic pain. All patients will already have undergone empiric programming of the stimulator using conventional settings (typically 40-60 Hz, 350-450 usec pulse width). However, other stimulation parameters, including high-frequency stimulation, are also feasible and FDA-approved using the implanted device, and it is possible to do this without producing a sensory percept, which makes it possible to test efficacy in a double blind manner. For this study, two different stimulation parameters will be tested during four two-week periods: 1000 Hz and placebo. Clinical response and side effect profile for each setting will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- All subjects underwent two weeks of conventional stimulation, followed by randomization to receive either subthreshold high-density (HD) or sham stimulation; this was followed by a crossover during which the participants who had received subthreshold HD stimulation were treated with sham and vice versa.
| Arm | Type | Receives |
|---|---|---|
| High-Frequency Stimulation, Then Placebo Stimulation | Experimental | Device: High-frequency stimulation, Device: Sham StimulationParticipants first receive sub-threshold high-frequency spinal cord stimulation (1200 Hz frequency, 200 μsec pulse width, and an amplitude 90% of the threshold for detection of a sensory percept) for 2 weeks. After a 2-week washout period, they then receive sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks. |
| Placebo Stimulation, Then High-Frequency Stimulation | Sham comparator | Device: High-frequency stimulation, Device: Sham StimulationParticipants first receive sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks. After a 2-week washout period, they then receive sub-threshold high-frequency spinal cord stimulation (1200 Hz frequency, 200 μsec pulse width, and an amplitude 90% of the threshold for detection of a sensory percept) for 2 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years
- Diagnosis of chronic neuropathic pain for which placement of electrodes into the spinal column is planned for clinical indications (failed back surgery syndrome, peripheral neuropathy or complex regional pain syndrome)
- History of implantation of spinal cord stimulation system with rechargeable implanted neurostimulator
Key exclusion criteria (4 listed)
- Significant dementia or other condition preventing informed consent by the patient.
- Current drug or alcohol abuse or dependence.
- Uncontrolled depression or anxiety or failure to pass psychological screening for spinal cord stimulation.
- Inability or unwillingness to cooperate with clinical testing.
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 |
|---|---|---|
| High-frequency stimulationPatients in this group will receive sub-threshold high-frequency (aka 1200Hz) spinal cord stimulation for 2 weeks. | Device | High-Frequency Stimulation, Then Placebo Stimulation, Placebo Stimulation, Then High-Frequency Stimulation |
| Sham StimulationPatients in this group will receive receive sham spinal cord stimulation (aka no stimulation) for 2 weeks. | Device | High-Frequency Stimulation, Then Placebo Stimulation, Placebo Stimulation, Then High-Frequency Stimulation |
Primary outcome
Visual Analog Pain Scale
Time frame: 8 weeks
Assessment of overall degree of back and leg pain during each phase of stimulation (ie conventional baseline stimulation, high-density stimulation, conventional "washout" stimulation, and sham stimulation). Scores range from 0 - 100, with a higher score indicating more pain.
4 secondary outcomes
Change in Brief Pain Inventory (BPI)
Time frame: 8 weeks
Change in SF-36
Time frame: 8 weeks
Pain Vigilance and Awareness Questionnaire (PVAQ)
Time frame: 8 weeks
Number of Patients With Side Effects of Stimulation
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26481726Sweet J, Badjatiya A, Tan D, Miller J. Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series. Neuromodulation. 2016 Apr;19(3):260-7. doi: 10.1111/ner.12357. Epub 2015 Oct 20.
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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.
Jennifer A Sweet, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency stimulation in people with Spinal Cord Stimulation and High-frequency Stimulation, run by Case Western Reserve 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 21 May 2024. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analog Pain Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05283863, which also lists 1 linked publication.
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 21 May 2024.