Chronic PainDYNAMONCT05968664
Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation
A study testing Spinal Cord Stimulator in people with Chronic Pain and Pain, Neuropathic, run by Ashwin Viswanathan at 1 site in United States.
Trial summary
The goal of this study is to compare pain outcomes achieved by spinal cord stimulation (SCS) using time varying stimulation patterns with pain outcomes achieved by current standard of care SCS. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Pain, Pain, Neuropathic, Neuropathic Pain
- What is being tested?
- Spinal Cord Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent
- Age ≥ 22
- Chronic pain of the trunk and/or limbs for at least 6 months
- Baseline average daily overall pain score of >60 (on a scale of 0-100mm) on the Visual Analog Scale related to pain of the back and/or limbs
- Failed ≥3 medically supervised treatments (i.e. pain medications, physical therapy, facet joint/medial branch nerve blocks, acupuncture), and treatment with >2 classes of medications
- Stable pain-related medication regimen 4 weeks prior to the trial. Patients will be asked to not increase or add pain-related medication during the study period
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- No back surgery within 6 months prior to Screening
- Consumed an average total daily morphine equivalent of ≤200 mg during the 30 days prior to Screening.
- Baseline Oswestry Disability Index score ≥40 and ≤80
- Eligible candidate for SCS from a psychological and psychiatric standpoint as determined within 180 days prior to Baseline Visit, per site's routine screening process
- Able to independently read and complete all questionnaires and assessments provided in English
- Female candidates of child-bearing potential agree to use contraception during the study period
- Deemed to be a good candidate for spinal cord stimulation by the PI, and a board certified pain management physician
- Willing to cooperate with study requirements
Who cannot join
- Patient exhibits catastrophization based on physician evaluation (e.g., average overall daily pain intensity of 100 on a 0-100mm visual analog scale, every day during the 7 days prior to Screening, based on patient recall
- Pain originating from peripheral vascular disease
- Active treatment for cancer in past 6 months
- Involved in disability litigation
- High surgical risk including documented history of allergic response to titanium or silicone, current systemic infection, or local infection in close proximity to anticipated surgical field
- Body mass index ≥ 45 at Screening
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- Terminal illness with anticipated survival < 12 months
- Participant is immunocompromised
- Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
- Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
- Previous spinal cord stimulation trial/implant or is already implanted with an active implantable device(s) (e.g. drug pump, implantable pulse generator)
- A pregnant female or a female of childbearing potential planning to get pregnant during the course of the study
- Plan to receive any massage or manipulation directly over the leads or by the anticipated location of the IPG or treatments that involve sudden jerking motions of the torso at any
- Existing medical condition that is likely to require the use of diathermy
- Any injury or medical/psychological condition that might be significantly exacerbated by the implant surgery or the presence of an implantable stimulator or otherwise compromise subject safety
- Unable to operate the study devices including wrist-worn biosensor and mobile app
- Documented history of substance abuse or dependency in the 6 months prior to baseline
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Aswhin Viswanathan, MD
About this study
The goal of this study is to compare pain outcomes achieved by spinal cord stimulation (SCS) using time varying stimulation patterns with pain outcomes achieved by current standard of care SCS.
Read the detailed description
The researchers will conduct a traditional exploratory feasibility study using an investigational device to compare the clinical outcomes using time varying pulse (TVP) waveforms against time-invariant pulse (TIP) waveforms using both paresthesia and paresthesia-free SCS therapies. The therapy longevity of TVPs and TIPS will also be evaluated by tracking therapy efficacy through a long-term follow-up phase, using multiple pain assessments and at-home digital data collection.
- Conditions
- Chronic Pain, Pain, Neuropathic, Neuropathic Pain
- Being tested
- Spinal Cord Stimulator
- Keywords
- Chronic pain, Spinal Cord Stimulation, Spinal cord, Neuropathy
- Medical subject headings
- Chronic Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulatorDevice
Spinal Cord Stimulator modified to deliver Time Variant Pulse (TVP) stimulation.
Spinal Cord StimulatorDevice
Spinal Cord Stimulator to deliver standard of care Time Invariant Pulse (TIP) stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Time Invariant Pulse(TIP) Stimulation | Active comparator | The control arm for this study will be the Time Invariant Pulse stimulation which is used in standard of care Spinal Cord Stimulation therapy. TIP tonic stimulation is delivered with fixed amplitude, pulse width, and frequency parameters. Receives: Device: Spinal Cord Stimulator |
| Time Variant Pulse (TVP) Stimulation | Experimental | The time variant pulse (TVP) stimulation will serve as the experimental arm for this study. There are two ways of delivering TVP stimulation to the spinal cord. TVP stimulation can either vary in intensity or it can vary rate, referred to as intensity-modulated TVP or rate-modulated TVP, respectively. Receives: Device: Spinal Cord Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient responder rate
The primary endpoint for this trial will be a comparison of the percentage of patients achieving at least a 50% reduction in pain during the TIP stimulation block with the percentage of patients achieving at least a 50% reduction in pain during either TVP stimulation block.
Measured: Patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Aug 2024
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ashwin Viswanathan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Ashwin Viswanathan, Baylor College of Medicine
- Investigators
- Ashwin Viswanathan, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968664
- Sponsor's protocol ID
- H-49405
- Other IDs
- 4UH3NS121563-02
- Acronym
- DYNAMO
- Status last verified
- Jun 2024
- First submitted
- 7 Jul 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation
- ClinicalTrials.gov ID
- NCT05968664
- Acronym / sponsor ID
- DYNAMO / H-49405
- Conditions
- Chronic Pain, Pain, Neuropathic, Neuropathic Pain
- Keywords
- Chronic pain, Spinal Cord Stimulation, Spinal cord, Neuropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Ashwin ViswanathanUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Boston Scientific Corporation
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 1 Aug 2023 (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 compare pain outcomes achieved by spinal cord stimulation (SCS) using time varying stimulation patterns with pain outcomes achieved by current standard of care SCS.
Detailed description
The researchers will conduct a traditional exploratory feasibility study using an investigational device to compare the clinical outcomes using time varying pulse (TVP) waveforms against time-invariant pulse (TIP) waveforms using both paresthesia and paresthesia-free SCS therapies. The therapy longevity of TVPs and TIPS will also be evaluated by tracking therapy efficacy through a long-term follow-up phase, using multiple pain assessments and at-home digital data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time Invariant Pulse(TIP) Stimulation | Active comparator | Device: Spinal Cord StimulatorThe control arm for this study will be the Time Invariant Pulse stimulation which is used in standard of care Spinal Cord Stimulation therapy. TIP tonic stimulation is delivered with fixed amplitude, pulse width, and frequency parameters. |
| Time Variant Pulse (TVP) Stimulation | Experimental | Device: Spinal Cord StimulatorThe time variant pulse (TVP) stimulation will serve as the experimental arm for this study. There are two ways of delivering TVP stimulation to the spinal cord. TVP stimulation can either vary in intensity or it can vary rate, referred to as intensity-modulated TVP or rate-modulated TVP, respectively. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ability to provide informed consent
- Age ≥ 22
- Chronic pain of the trunk and/or limbs for at least 6 months
- Baseline average daily overall pain score of >60 (on a scale of 0-100mm) on the Visual Analog Scale related to pain of the back and/or limbs
- Failed ≥3 medically supervised treatments (i.e. pain medications, physical therapy, facet joint/medial branch nerve blocks, acupuncture), and treatment with >2 classes of medications
Key exclusion criteria (17 listed)
- Patient exhibits catastrophization based on physician evaluation (e.g., average overall daily pain intensity of 100 on a 0-100mm visual analog scale, every day during the 7 days prior to Screening, based on patient recall
- Pain originating from peripheral vascular disease
- Active treatment for cancer in past 6 months
- Involved in disability litigation
- High surgical risk including documented history of allergic response to titanium or silicone, current systemic infection, or local infection in close proximity to anticipated surgical field
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 |
|---|---|---|
| Spinal Cord StimulatorSpinal Cord Stimulator modified to deliver Time Variant Pulse (TVP) stimulation. | Device | Time Variant Pulse (TVP) Stimulation |
| Spinal Cord StimulatorSpinal Cord Stimulator to deliver standard of care Time Invariant Pulse (TIP) stimulation. | Device | Time Invariant Pulse(TIP) Stimulation |
Primary outcome
Change in Patient responder rate
Time frame: Patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each.
The primary endpoint for this trial will be a comparison of the percentage of patients achieving at least a 50% reduction in pain during the TIP stimulation block with the percentage of patients achieving at least a 50% reduction in pain during either TVP stimulation block.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
Ashwin Viswanathan, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulator in people with Chronic Pain and Pain, Neuropathic, run by Ashwin Viswanathan 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 14 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 22 Nov 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashwin Viswanathan, MD (7132138181, ashwinv@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient responder rate (time frame: Patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each.). 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 22 Nov 2024.