Injuries, Spinal CordNCT04530955
Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)
A study testing Prometra II Programmable Pump - Flowonix Medical in people with Injuries, Spinal Cord and CVA (Cerebrovascular Accident), run by Culicchia Neurological Clinic at 1 site in United States.
Trial summary
Comparing the efficacy of Intracthecal Baclofen dose between the Prometra II and Medtronic SynchroMed II for patients with spasticity and with current a current SyncroMed II pump needing replacement. Read more about this study
- Who is it for?
- Ages 22 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Injuries, Spinal Cord, CVA (Cerebrovascular Accident), Traumatic Brain Injury
- What is being tested?
- Prometra II Programmable Pump - Flowonix Medical
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2020to Jun 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be male or female between the ages of 22 and 85 years
- Be capable of giving informed consent (or a legally authorized representative) and completing assessments required by the study
- Have modified Ashworth scores within 3 months prior to valve-gated pump implant
- Have an active existing SynchroMed II intrathecal drug delivery system needing replacement
- Existing ITB patient with spasticity of any origin.
- Have stable drug dosage for at least 3 months prior to valve-gated pump implant
- Be an appropriate candidate for surgery
- Be able to comply with required study visits and assessments including English proficiency
Who cannot join
- Be terminally ill and/or have a life expectancy of less than 12 months
- Be a pregnant/lactating woman.
- Have a systemic or local infection (contraindicated for pump implantation)
- Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Culicchia Neurological Clinic
Marrero, Louisiana, 70072
Cassi Bodenheimer, RN, 504-340-6976, cbodenheimer@culicchianeuro.com
Andrea Toomer, MD
About this study
Official title: Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS): A Randomized, Controlled, Multi-center, Prospective Study Evaluating Dose Reduction in ITB Patients.
Comparing the efficacy of Intracthecal Baclofen dose between the Prometra II and Medtronic SynchroMed II for patients with spasticity and with current a current SyncroMed II pump needing replacement.
Read the detailed description
The Prometra II Programmable Pump is a battery-powered, teardrop-shaped, valve-gated pump with titanium housing and triple redundancy flow controls to deliver precise amounts of medication into the intrathecal space via the separately provided Intrathecal Catheter. The Prometra Pump is remotely programmed by the Prometra Clinician Programmer to deliver medication at a constant or variable rate or to periodically deliver a drug dose at a distinct interval of time or with an immediate infusion, demand bolus.
The Prometra II Pump differs from the SynchroMed II due to the way in which it delivers medication. The Prometra pump does not have motor, gears, rollers or tubing s. Instead, the Prometra II Pump uses a pressure-driven, valve-gated delivery system. When the inlet valve opens, the pressure behind the reservoir pushes drug into the dosing chamber and the outlet valve prevents flow out of the dosing chamber or into the catheter until opened (after inlet valve closes). When the outlet valve opens, the pressure in the dosing chamber pushes the medication (2 to 3 microliters) out and then the outlet valve closes. The pump is programmed to control flow by alternately opening the inlet and outlet valves. Medication flows from the higher pressure in the reservoir to the lower pressure in the dosing chamber when the inlet valve is opened.
The only moving parts in the Prometra II Pump are the valves. The titanium fluid path is not permeable to fluids within the drug path since titanium is inert. The titanium dosing chamber and valve-gated fluid path does not allow any drug to permeate out of the chamber or drug path as is known to occur with tubing in the peristaltic pumps. This allows baclofen to be delivered more reliably in the Prometra II Pump.
As a result, the Prometra II Pump may offer several advantages over peristaltic pumps:
- The pressure-driven, valve-gated delivery mechanism has been shown to have different effects on drug dispersion in the CSF compared to peristaltic pump delivery.
- Any changes in reservoir gas pressure due to fluctuations in refill levels or environmental factors has minimal effect on Prometra II Pump dose accuracy.
- 100% titanium Prometra II Pump fluid path is not permeable to drug solutions unlike peristaltic pump tubing, etc. which can result in pump corrosion events and peristaltic rotor stalls.
- Improved dose accuracy is expected during each refill cycle with the Prometra II Pump as well as over the pump lifetime compared to peristaltic pumps.
- Improved durability and battery life are expected for the Prometra II Pump compared to peristaltic pumps.
This randomized study has two arms (Control Arm and Study Arm) and was designed to explore if the valve-gated pump requires less drug to manage patient spasticity than the prior standard peristaltic pump in the same patient. The newly implanted valve-gated pump will be programmed to deliver a 20% reduction (Study Arm) of baclofen that was being delivered in the peristaltic pump prior to explant. Modified Ashworth scores (MAS) will be evaluated over time (prospectively for the valve-gated pump and retrospectively via chart review for the peristaltic pump). A dose reduction of 20% was selected based on anecdotal evidence observed during use of the Prometra II Pump in pain patients. In the second arm of the study (Control Arm), the newlyimplanted valve-gated pump will be programmed to deliver the same baclofen dose that was being delivered in the peristaltic pump prior to explant. As with the Study Arm, MMAS will be evaluated over time (prospectively for the valve-gated pump and retrospectively via chart review for the peristaltic pump).
This investigator-initiated trial is designed to evaluate intrathecal drug pumps in the post market setting. When a patient needs an end of battery life peristaltic pump replacement the physician may decide to implant the valve-gated pump under standard of care for the individual patient. This study will collect retrospective peristaltic pump dosage and MAS data from the last pump refill or visit within the last 3 months prior to explant and valve-gated pump implant. Prospective valve-gated pump medication dosage and MAS data will be collected at the 2 week, 4 week and 3 month exit visit (not to exceed 4 months). This study design will reduce patient medication dose delivered by the valve-gated pump by 20% for comparison to historical dosing and management provided by the peristaltic pump.
This study will employ a single-blinded approach in which study participants will not be notified of pump dosing changes. After valve-gated pump implant and dose reduction, the appropriate spasticity therapy will be provided to adequately address spasticity management in the opinion of the study investigator using standard of care processes.
- Conditions
- Injuries, Spinal Cord, CVA (Cerebrovascular Accident), Traumatic Brain Injury, MS (Multiple Sclerosis), Muscle Spasticity, Cerebral Palsy, Spastic
- Being tested
- Prometra II Programmable Pump - Flowonix Medical
- Keywords
- Spasticity
- Medical subject headings
- Spinal Cord Injuries, Stroke, Brain Injuries, Traumatic, Multiple Sclerosis, Muscle Spasticity, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prometra II Programmable Pump - Flowonix MedicalDevice
The valve gated Prometra II Programmable Pump will be replacing the prior peristaltic Synchromed II pump and a 20% dose decrease will be performed at the time of the replacement.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Patients randomized to the Control Arm that have been implanted with the valve-gated pump will be started on an equivalent dose (without change to the medication concentration) as prior to implant. If at any time during the patients' treatment it is determined by the investigator that the patients' treatment dose needs to be modified, the dose can be modified as clinically indicated. Multiple dosing decreases may be performed if the patient is clinically demonstrating a reduction in spasticity that is profound and negatively impacting function, or if the patient is demonstrating signs of baclofen overdose. The criteria for dosing decrease will be clinical discretion. |
| Study Arm | Active comparator | Patients randomized to the Study Arm will be started on a 20% dose reduction (without change to the medication concentration) through the newly implanted valve-gated pump. If at any time during the patients' treatment it is determined by the investigator that the patients' treatment dose needs to be increased or decreased, the dose can be increased/decreased as clinically indicated. If the dose increases with the valve-gated pump reach the patients' baseline dose and the patient's spasticity is worse than his or her spasticity at baseline, then the patient will be considered a primary endpoint failure.
The criteria for dosing increase will be clinical discretion. Receives: Device: Prometra II Programmable Pump - Flowonix Medical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of spasticity control with Synchromed II versus Prometra II
To evaluate that a Baclofen dose reduction delivered through a valve-gated intrathecal drug delivery system (Prometra II) provides spasticity control no less than the baseline dose delivered through a peristaltic intrathecal drug delivery system (SynchroMed II).
NOTE: In this study, a modified Ashworth scores will be prospectively collected for valve-gated pumps and will be compared to retrospectively collected modified Ashworth scores prior to peristaltic pump explant.
Measured: 3 months
Secondary outcomes (1)
Comparison of patient report of spasm frequency with Synchromed II versus Prometra II
To evaluate change in patient self-assessment of spasticity prior to peristaltic pump explant compared to scores after conversion to a valve-gated pump.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start24 Sep 2020
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Injuries, Spinal CordStudies 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
- Parallel groups
- Model description
- Randomized, open label, single-blind, multi-center, post-market study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Culicchia Neurological Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Flowonix Medical
- Responsible party
- Principal investigator, Andrea Toomer, Culicchia Neurological Clinic
- Investigators
- Andrea Toomer, MD, Principal investigator, Culicchia Neurological Clinic Partner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530955
- Sponsor's protocol ID
- AT-001
- Status last verified
- Sep 2020
- First submitted
- 18 Aug 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ordia JI, Fischer E, Adamski E, Chagnon KG, Spatz EL. Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin. Neuromodulation. 2002 Jan;5(1):16-24. doi: 10.1046/j.1525-1403.2002._2004.x.
PubMed 22151777Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
PubMed 3809245Lewis KS, Mueller WM. Intrathecal baclofen for severe spasticity secondary to spinal cord injury. Ann Pharmacother. 1993 Jun;27(6):767-74. doi: 10.1177/106002809302700618.
PubMed 8329801Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil. 2006 Nov;87(11):1509-15. doi: 10.1016/j.apmr.2006.08.323.
PubMed 17084128Saulino M, Ivanhoe CB, McGuire JR, Ridley B, Shilt JS, Boster AL. Best Practices for Intrathecal Baclofen Therapy: Patient Selection. Neuromodulation. 2016 Aug;19(6):607-15. doi: 10.1111/ner.12447. Epub 2016 Jul 19.
PubMed 27434197Middel B, Kuipers-Upmeijer H, Bouma J, Staal M, Oenema D, Postma T, Terpstra S, Stewart R. Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity. J Neurol Neurosurg Psychiatry. 1997 Aug;63(2):204-9. doi: 10.1136/jnnp.63.2.204.
PubMed 9285459Albright AL, Gilmartin R, Swift D, Krach LE, Ivanhoe CB, McLaughlin JF. Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg. 2003 Feb;98(2):291-5. doi: 10.3171/jns.2003.98.2.0291.
PubMed 12593613
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS): A Randomized, Controlled, Multi-center, Prospective Study Evaluating Dose Reduction in ITB Patients.
- ClinicalTrials.gov ID
- NCT04530955
- Acronym / sponsor ID
- AT-001
- Conditions
- Injuries, Spinal Cord, CVA (Cerebrovascular Accident), Traumatic Brain Injury, MS (Multiple Sclerosis), Muscle Spasticity, Cerebral Palsy, Spastic
- Keywords
- Spasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Culicchia Neurological ClinicUniversity, hospital or other
- Collaborators
- Flowonix Medical
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 28 Aug 2020 (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.
Comparing the efficacy of Intracthecal Baclofen dose between the Prometra II and Medtronic SynchroMed II for patients with spasticity and with current a current SyncroMed II pump needing replacement.
Detailed description
The Prometra II Programmable Pump is a battery-powered, teardrop-shaped, valve-gated pump with titanium housing and triple redundancy flow controls to deliver precise amounts of medication into the intrathecal space via the separately provided Intrathecal Catheter. The Prometra Pump is remotely programmed by the Prometra Clinician Programmer to deliver medication at a constant or variable rate or to periodically deliver a drug dose at a distinct interval of time or with an immediate infusion, demand bolus.
The Prometra II Pump differs from the SynchroMed II due to the way in which it delivers medication. The Prometra pump does not have motor, gears, rollers or tubing s. Instead, the Prometra II Pump uses a pressure-driven, valve-gated delivery system. When the inlet valve opens, the pressure behind the reservoir pushes drug into the dosing chamber and the outlet valve prevents flow out of the dosing chamber or into the catheter until opened (after inlet valve closes). When the outlet valve opens, the pressure in the dosing chamber pushes the medication (2 to 3 microliters) out and then the outlet valve closes. The pump is programmed to control flow by alternately opening the inlet and outlet valves. Medication flows from the higher pressure in the reservoir to the lower pressure in the dosing chamber when the inlet valve is opened.
The only moving parts in the Prometra II Pump are the valves. The titanium fluid path is not permeable to fluids within the drug path since titanium is inert. The titanium dosing chamber and valve-gated fluid path does not allow any drug to permeate out of the chamber or drug path as is known to occur with tubing in the peristaltic pumps. This allows baclofen to be delivered more reliably in the Prometra II Pump.
As a result, the Prometra II Pump may offer several advantages over peristaltic pumps:
- The pressure-driven, valve-gated delivery mechanism has been shown to have different effects on drug dispersion in the CSF compared to peristaltic pump delivery.
- Any changes in reservoir gas pressure due to fluctuations in refill levels or environmental factors has minimal effect on Prometra II Pump dose accuracy.
- 100% titanium Prometra II Pump fluid path is not permeable to drug solutions unlike peristaltic pump tubing, etc. which can result in pump corrosion events and peristaltic rotor stalls.
- Improved dose accuracy is expected during each refill cycle with the Prometra II Pump as well as over the pump lifetime compared to peristaltic pumps.
- Improved durability and battery life are expected for the Prometra II Pump compared to peristaltic pumps.
This randomized study has two arms (Control Arm and Study Arm) and was designed to explore if the valve-gated pump requires less drug to manage patient spasticity than the prior standard peristaltic pump in the same patient. The newly implanted valve-gated pump will be programmed to deliver a 20% reduction (Study Arm) of baclofen that was being delivered in the peristaltic pump prior to explant. Modified Ashworth scores (MAS) will be evaluated over time (prospectively for the valve-gated pump and retrospectively via chart review for the peristaltic pump). A dose reduction of 20% was selected based on anecdotal evidence observed during use of the Prometra II Pump in pain patients. In the second arm of the study (Control Arm), the newlyimplanted valve-gated pump will be programmed to deliver the same baclofen dose that was being delivered in the peristaltic pump prior to explant. As with the Study Arm, MMAS will be evaluated over time (prospectively for the valve-gated pump and retrospectively via chart review for the peristaltic pump).
This investigator-initiated trial is designed to evaluate intrathecal drug pumps in the post market setting. When a patient needs an end of battery life peristaltic pump replacement the physician may decide to implant the valve-gated pump under standard of care for the individual patient. This study will collect retrospective peristaltic pump dosage and MAS data from the last pump refill or visit within the last 3 months prior to explant and valve-gated pump implant. Prospective valve-gated pump medication dosage and MAS data will be collected at the 2 week, 4 week and 3 month exit visit (not to exceed 4 months). This study design will reduce patient medication dose delivered by the valve-gated pump by 20% for comparison to historical dosing and management provided by the peristaltic pump.
This study will employ a single-blinded approach in which study participants will not be notified of pump dosing changes. After valve-gated pump implant and dose reduction, the appropriate spasticity therapy will be provided to adequately address spasticity management in the opinion of the study investigator using standard of care processes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, open label, single-blind, multi-center, post-market study
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Patients randomized to the Control Arm that have been implanted with the valve-gated pump will be started on an equivalent dose (without change to the medication concentration) as prior to implant. If at any time during the patients' treatment it is determined by the investigator that the patients' treatment dose needs to be modified, the dose can be modified as clinically indicated. Multiple dosing decreases may be performed if the patient is clinically demonstrating a reduction in spasticity that is profound and negatively impacting function, or if the patient is demonstrating signs of baclofen overdose. The criteria for dosing decrease will be clinical discretion. |
| Study Arm | Active comparator | Device: Prometra II Programmable Pump - Flowonix MedicalPatients randomized to the Study Arm will be started on a 20% dose reduction (without change to the medication concentration) through the newly implanted valve-gated pump. If at any time during the patients' treatment it is determined by the investigator that the patients' treatment dose needs to be increased or decreased, the dose can be increased/decreased as clinically indicated. If the dose increases with the valve-gated pump reach the patients' baseline dose and the patient's spasticity is worse than his or her spasticity at baseline, then the patient will be considered a primary endpoint failure. The criteria for dosing increase will be clinical discretion. |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be male or female between the ages of 22 and 85 years
- Be capable of giving informed consent (or a legally authorized representative) and completing assessments required by the study
- Have modified Ashworth scores within 3 months prior to valve-gated pump implant
- Have an active existing SynchroMed II intrathecal drug delivery system needing replacement
- Existing ITB patient with spasticity of any origin.
Key exclusion criteria (4 listed)
- Be terminally ill and/or have a life expectancy of less than 12 months
- Be a pregnant/lactating woman.
- Have a systemic or local infection (contraindicated for pump implantation)
- Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments
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 |
|---|---|---|
| Prometra II Programmable Pump - Flowonix MedicalThe valve gated Prometra II Programmable Pump will be replacing the prior peristaltic Synchromed II pump and a 20% dose decrease will be performed at the time of the replacement. | Device | Study Arm |
Primary outcome
Comparison of spasticity control with Synchromed II versus Prometra II
Time frame: 3 months
To evaluate that a Baclofen dose reduction delivered through a valve-gated intrathecal drug delivery system (Prometra II) provides spasticity control no less than the baseline dose delivered through a peristaltic intrathecal drug delivery system (SynchroMed II). NOTE: In this study, a modified Ashworth scores will be prospectively collected for valve-gated pumps and will be compared to retrospectively collected modified Ashworth scores prior to peristaltic pump explant.
1 secondary outcome
Comparison of patient report of spasm frequency with Synchromed II versus Prometra II
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Background: PubMed 22151777Ordia JI, Fischer E, Adamski E, Chagnon KG, Spatz EL. Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin. Neuromodulation. 2002 Jan;5(1):16-24. doi: 10.1046/j.1525-1403.2002._2004.x.
- Results publication: PubMed 3809245Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
- Results publication: PubMed 8329801Lewis KS, Mueller WM. Intrathecal baclofen for severe spasticity secondary to spinal cord injury. Ann Pharmacother. 1993 Jun;27(6):767-74. doi: 10.1177/106002809302700618.
- Results publication: PubMed 17084128Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil. 2006 Nov;87(11):1509-15. doi: 10.1016/j.apmr.2006.08.323.
- Results publication: PubMed 27434197Saulino M, Ivanhoe CB, McGuire JR, Ridley B, Shilt JS, Boster AL. Best Practices for Intrathecal Baclofen Therapy: Patient Selection. Neuromodulation. 2016 Aug;19(6):607-15. doi: 10.1111/ner.12447. Epub 2016 Jul 19.
- Results publication: PubMed 9285459Middel B, Kuipers-Upmeijer H, Bouma J, Staal M, Oenema D, Postma T, Terpstra S, Stewart R. Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity. J Neurol Neurosurg Psychiatry. 1997 Aug;63(2):204-9. doi: 10.1136/jnnp.63.2.204.
- Results publication: PubMed 12593613Albright AL, Gilmartin R, Swift D, Krach LE, Ivanhoe CB, McLaughlin JF. Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg. 2003 Feb;98(2):291-5. doi: 10.3171/jns.2003.98.2.0291.
- Individual participant dataSharing planned: No
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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.
Andrea Toomer, MD principal investigator
Culicchia Neurological Clinic Partner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prometra II Programmable Pump - Flowonix Medical in people with Injuries, Spinal Cord and CVA (Cerebrovascular Accident), run by Culicchia Neurological Clinic 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 8 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: status not confirmed, as of the sponsor's last update on 28 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cassi Bodenheimer, RN (504-340-6976, cbodenheimer@culicchianeuro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of spasticity control with Synchromed II versus Prometra II (time frame: 3 months). 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 NCT04530955, which also lists 7 linked publications.
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 28 Sep 2020.