Chronic PainMOSAICNCT07190807
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
A study testing Boston Scientific WaveWriter Alpha™ SCS Systems in people with Chronic Pain and Intractable Pain, run by Boston Scientific Corporation at 7 sites in United States.
Trial summary
Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU). In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Intractable Pain, Low Back Pain
- What is being tested?
- Boston Scientific WaveWriter Alpha™ SCS Systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Nov 2025to May 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent spinal pain syndrome (PSPS) Type I (or non-surgical refractory back pain), or PSPS Type II (Failed Back Surgery Syndrome, FBSS) diagnosis.
- Diagnosed with chronic pain of the trunk and/or limbs for at least 6 months.
- 18 years of age or older when written informed consent is obtained
- Able to independently read and complete all questionnaires and assessments provided in English.
- Signed a valid, IRB or EC approved informed consent form (ICF) provided in English.
Who cannot join
- Any pain-related diagnosis, medical or psychological condition that, in the Investigator's judgment might confound reporting of study outcomes (e.g., vascular or neurogenic claudication, osteoarthritis, plantar fasciitis, pelvic pain, anginal pain, chronic migraine, acute herniated disc, malignancy, untreated major depression, injury claim).
- Significant cognitive impairment at Screening and Baseline visit that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
- A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
- Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Orlando Health Neuroscience Institute
Clermont, Florida, 24711
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Institute of Precision Pain Medicine
Corpus Christi, Texas, 78414
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, 29601
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Denver Back Pain Specialists
Greenwood, Colorado, 80111
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70115
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Fox Chase Pain Management
Trevose, Pennsylvania, 19053
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
About this study
Official title: Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control (MOSAIC Study)
Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU).
In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.
- Conditions
- Chronic Pain, Intractable Pain, Low Back Pain, Chronic Low-back Pain, Chronic Leg Pain, Leg Pain
- Being tested
- Boston Scientific WaveWriter Alpha™ SCS Systems
- Keywords
- Spinal Cord Stimulation
- Medical subject headings
- Chronic Pain, Pain, Intractable, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Scientific WaveWriter Alpha™ SCS SystemsDevice
Time Varied Pulse (TVP)-SCS settings
| Study group | Role | What they receive |
|---|---|---|
| Time Varied Pulse (TVP)-SCS settings | Experimental | Not described Receives: Device: Boston Scientific WaveWriter Alpha™ SCS Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted Pain Responder Rate
Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
Measured: 3 months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start7 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionMay 2029 (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.
- More trials run by Boston Scientific CorporationThe 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
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalie M Bloom Lyons, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190807
- Sponsor's protocol ID
- A4116
- Acronym
- MOSAIC
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control (MOSAIC Study)
- ClinicalTrials.gov ID
- NCT07190807
- Acronym / sponsor ID
- MOSAIC / A4116
- Conditions
- Chronic Pain, Intractable Pain, Low Back Pain, Chronic Low-back Pain, Chronic Leg Pain, Leg Pain
- Keywords
- Spinal Cord Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 24 Sep 2025 (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.
Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU).
In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time Varied Pulse (TVP)-SCS settings | Experimental | Device: Boston Scientific WaveWriter Alpha™ SCS Systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Persistent spinal pain syndrome (PSPS) Type I (or non-surgical refractory back pain), or PSPS Type II (Failed Back Surgery Syndrome, FBSS) diagnosis.
- Diagnosed with chronic pain of the trunk and/or limbs for at least 6 months.
- 18 years of age or older when written informed consent is obtained
- Able to independently read and complete all questionnaires and assessments provided in English.
- Signed a valid, IRB or EC approved informed consent form (ICF) provided in English.
Key exclusion criteria (4 listed)
- Any pain-related diagnosis, medical or psychological condition that, in the Investigator's judgment might confound reporting of study outcomes (e.g., vascular or neurogenic claudication, osteoarthritis, plantar fasciitis, pelvic pain, anginal pain, chronic migraine, acute herniated disc, malignancy, untreated major depression, injury claim).
- Significant cognitive impairment at Screening and Baseline visit that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
- A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
- Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.
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 |
|---|---|---|
| Boston Scientific WaveWriter Alpha™ SCS SystemsTime Varied Pulse (TVP)-SCS settings | Device | Time Varied Pulse (TVP)-SCS settings |
Primary outcome
Targeted Pain Responder Rate
Time frame: 3 months post-activation
Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
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 13 Oct 2026.
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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.
Natalie M Bloom Lyons study director
Boston Scientific Corporation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boston Scientific WaveWriter Alpha™ SCS Systems in people with Chronic Pain and Intractable Pain, run by Boston Scientific Corporation at 7 sites 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 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Thanh Hoang (855-213-9890, BSNClinicalTrials@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Targeted Pain Responder Rate (time frame: 3 months post-activation). 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 13 Oct 2026.