MedDataX Logo

DBS of PPN to Improve Walking in Chronic SCI Patients

NCT ID: NCT04325165

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-11-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injuries Spinal Injuries Spinal Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1: Chronic SCI subjects

These subjects will undergo:

1. Bilateral implantation of PPN DBS electrodes;
2. Electrical stimulation of the DBS electrodes and
3. Intensive locomotor training

Group Type EXPERIMENTAL

DBS Implantation

Intervention Type DEVICE

Bilateral implantation of PPN DBS electrodes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DBS Implantation

Bilateral implantation of PPN DBS electrodes

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Toronto Rehabilitation Institute

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andres M. Lozano

Professor and Chairman, Dan Family Chair in Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andres Lozano

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

159038

Identifier Type: -

Identifier Source: org_study_id