DBS of PPN to Improve Walking in Chronic SCI Patients | NCT04325165

Studies
DBS of PPN to Improve Walking in Chronic SCI Patients

NCT04325165

Sponsor

University Health Network, Toronto

Status

Withdrawn

Last Update Posted

Nov 3, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Spinal Cord Injuries
Spinal Injuries
Spinal Fractures

Interventions

DBS Implantation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment issues

Expanded Access Info

Start Date

Jun 30, 2015Actual

Primary Completion Date

Nov 26, 2018Estimated

Completion Date

Nov 26, 2018Actual

First Submitted Date

Jan 6, 2020

First Submission Date that Met QC Criteria

Mar 25, 2020

First Posted Date

Mar 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2020

Last Update Posted Date

Nov 3, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andres M. Lozano, Professor and Chairman, Dan Family Chair in Neurosurgery, University Health Network, TorontoPrincipal Investigator

Lead Sponsor

University Health Network, TorontoOTHER

Collaborators

Name	Class
Toronto Rehabilitation Institute	OTHER

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1: Chronic SCI subjects	Experimental	These subjects will undergo: Bilateral implantation of PPN DBS electrodes; Electrical stimulation of the DBS electrodes and Intensive locomotor training	Device: DBS Implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DBS Implantation	Device	Bilateral implantation of PPN DBS electrodes	1: Chronic SCI subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 Year
Timed 10-meter walk test	Patients are assess by walking speed in metres per second over a 10-metre walk distance.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andres Lozano	University Health Network, Toronto	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries
D013124	Spinal Injuries
D016103	Spinal Fractures

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

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Browse Branches

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