Spinal Cord InjuriesNCT04325165
DBS of PPN to Improve Walking in Chronic SCI Patients
A study testing DBS Implantation in people with Spinal Cord Injuries and Spinal Injuries, run by University Health Network, Toronto.
Trial summary
Spinal cord injury (SCI) is a devastating condition affecting over 1 million individuals in North America. SCI often results in severe motor impairments with few available treatments options. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Spinal Injuries, Spinal Fractures
- What is being tested?
- DBS Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2015to 26 Nov 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 (at time of enrolment)
- SCI that occurred greater than 2 years ago
- Current neurological status of AIS grade C or D, can stand with aids but not functionally ambulate
- Residence in GTA
Who cannot join
- Other substantial medical conditions causing physical restrictions, neurological deficits, or causing excessive risk of surgery
- Professional or other time commitments affecting availability for numerous hospital visits
- Contraindications to MRI (eg. metal in eye)
- Women that are pregnant (according to a bHCG serum/urine test at time of screening), or are actively seeking to become pregnant
About this study
Official title: Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus (PPN) to Improve Walking in Chronic Spinal Cord Injury (SCI) Patients
Spinal cord injury (SCI) is a devastating condition affecting over 1 million individuals in North America. SCI often results in severe motor impairments with few available treatments options. Recent groundbreaking research has demonstrated that deep brain stimulation (DBS) of the mesencephalic locomotor region (MLR) greatly improves locomotion in a rat model with incomplete SCI. The pedunculopontine nucleus (PPN - a specific nucleus within the MLR) in humans has already been established as an auxillary DBS target in Parkinson Disease (PD), to improve motor control and locomotion. DBS of other targets has also been safely used in humans with SCI for chronic pain. These findings suggest that DBS of the PPN may have potential as a therapeutic intervention in the SCI population to improve locomotion. Our goal is to conduct a pioneering study in 5 select motor-incomplete chronic SCI patients that cannot functionally ambulate to examine if bilateral DBS of the PPN improves walking
Read the detailed description
This prospective repeated measures study of the implantation of bilateral PPN electrodes in a small series of chronic SCI patients will aim to examine safety, feasibility, and potential efficacy. This research will investigate the effects of electrode implantation, electrical stimulation and intensive locomotion training over a 1-year period. Motor assessments will be performed at regular intervals with stimulation on and off in a double-blind fashion (subjects and researchers will be unaware of stimulation setting), to determine if subjects have improved ambulation with stimulation on compared with off, and if their ambulation improves over the course of the study observation period with stimulation on.
- Conditions
- Spinal Cord Injuries, Spinal Injuries, Spinal Fractures
- Being tested
- DBS Implantation
- Medical subject headings
- Spinal Cord Injuries, Spinal Injuries, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS ImplantationDevice
Bilateral implantation of PPN DBS electrodes
| Study group | Role | What they receive |
|---|---|---|
| 1: Chronic SCI subjects | Experimental | These subjects will undergo:
1. Bilateral implantation of PPN DBS electrodes;
2. Electrical stimulation of the DBS electrodes and
3. Intensive locomotor training Receives: Device: DBS Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walk assessment
Patients are assess by how a person walks or move their limbs. Patients will be asked to walk on a mat while the system captures gait patterns for both time (temporal) and space (spatial) through pressure sensors in a mat located in a walkway.
Measured: 1 Year
Timed 10-meter walk test
Patients are assess by walking speed in metres per second over a 10-metre walk distance.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start30 Jun 2015
- Primary completion26 Nov 2018 (estimated)
- Study completion26 Nov 2018
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Rehabilitation Institute
- Responsible party
- Principal investigator, Andres M. Lozano, University Health Network, Toronto
- Investigators
- Andres Lozano, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325165
- Sponsor's protocol ID
- 159038
- Status last verified
- Nov 2020
- First submitted
- 6 Jan 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus (PPN) to Improve Walking in Chronic Spinal Cord Injury (SCI) Patients
- ClinicalTrials.gov ID
- NCT04325165
- Acronym / sponsor ID
- 159038
- Conditions
- Spinal Cord Injuries, Spinal Injuries, Spinal Fractures
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Toronto Rehabilitation Institute
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 26 Nov 2018 (estimated)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 27 Mar 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.
Spinal cord injury (SCI) is a devastating condition affecting over 1 million individuals in North America. SCI often results in severe motor impairments with few available treatments options. Recent groundbreaking research has demonstrated that deep brain stimulation (DBS) of the mesencephalic locomotor region (MLR) greatly improves locomotion in a rat model with incomplete SCI. The pedunculopontine nucleus (PPN - a specific nucleus within the MLR) in humans has already been established as an auxillary DBS target in Parkinson Disease (PD), to improve motor control and locomotion. DBS of other targets has also been safely used in humans with SCI for chronic pain. These findings suggest that DBS of the PPN may have potential as a therapeutic intervention in the SCI population to improve locomotion. Our goal is to conduct a pioneering study in 5 select motor-incomplete chronic SCI patients that cannot functionally ambulate to examine if bilateral DBS of the PPN improves walking
Detailed description
This prospective repeated measures study of the implantation of bilateral PPN electrodes in a small series of chronic SCI patients will aim to examine safety, feasibility, and potential efficacy. This research will investigate the effects of electrode implantation, electrical stimulation and intensive locomotion training over a 1-year period. Motor assessments will be performed at regular intervals with stimulation on and off in a double-blind fashion (subjects and researchers will be unaware of stimulation setting), to determine if subjects have improved ambulation with stimulation on compared with off, and if their ambulation improves over the course of the study observation period with stimulation on.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1: Chronic SCI subjects | Experimental | Device: DBS ImplantationThese subjects will undergo: 1. Bilateral implantation of PPN DBS electrodes; 2. Electrical stimulation of the DBS electrodes and 3. Intensive locomotor training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65 (at time of enrolment)
- SCI that occurred greater than 2 years ago
- Current neurological status of AIS grade C or D, can stand with aids but not functionally ambulate
- Residence in GTA
Key exclusion criteria (4 listed)
- Other substantial medical conditions causing physical restrictions, neurological deficits, or causing excessive risk of surgery
- Professional or other time commitments affecting availability for numerous hospital visits
- Contraindications to MRI (eg. metal in eye)
- Women that are pregnant (according to a bHCG serum/urine test at time of screening), or are actively seeking to become pregnant
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 |
|---|---|---|
| DBS ImplantationBilateral implantation of PPN DBS electrodes | Device | 1: Chronic SCI subjects |
Primary outcome
Walk assessment
Time frame: 1 Year
Patients are assess by how a person walks or move their limbs. Patients will be asked to walk on a mat while the system captures gait patterns for both time (temporal) and space (spatial) through pressure sensors in a mat located in a walkway.
Timed 10-meter walk test
Time frame: 1 year
Patients are assess by walking speed in metres per second over a 10-metre walk distance.
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 3 Nov 2020.
- 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.
Andres Lozano principal investigator
University Health Network, Toronto
Questions about this trial
What is this clinical trial studying?
A study testing DBS Implantation in people with Spinal Cord Injuries and Spinal Injuries, run by University Health Network, Toronto.
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 4 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: withdrawn, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Walk assessment (time frame: 1 Year). The study lists 2 primary outcomes in all. 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 3 Nov 2020.