DBS of PPN to Improve Walking in Chronic SCI Patients

Status Withdrawn

Clinical 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. 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04325165
Study type	Interventional
Source	University Health Network, Toronto
Contact
Status	Withdrawn
Phase	N/A
Start date	June 30, 2015
Completion date	November 26, 2018

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06321172` - Muscle and Bone Changes After 6 Months of FES Cycling	N/A
Completed	`NCT03457714` - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting	`NCT05484557` - Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury	N/A
Suspended	`NCT05542238` - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury	N/A
Recruiting	`NCT05503316` - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System	N/A
Not yet recruiting	`NCT05506657` - Early Intervention to Promote Return to Work for People With Spinal Cord Injury	N/A
Recruiting	`NCT04105114` - Transformation of Paralysis to Stepping	Early Phase 1
Recruiting	`NCT03680872` - Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System	N/A
Completed	`NCT04221373` - Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation	N/A
Completed	`NCT00116337` - Spinal Cord Stimulation to Restore Cough	N/A
Completed	`NCT03898700` - Coaching for Caregivers of Children With Spinal Cord Injury	N/A
Recruiting	`NCT04883463` - Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury	N/A
Active, not recruiting	`NCT04881565` - Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES)	N/A
Active, not recruiting	`NCT04864262` - Photovoice for Spinal Cord Injury to Prevent Falls	N/A
Recruiting	`NCT04007380` - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI	N/A
Active, not recruiting	`NCT04544761` - Resilience in Persons Following Spinal Cord Injury
Completed	`NCT03220451` - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients	N/A
Terminated	`NCT03170557` - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation	N/A
Recruiting	`NCT04811235` - Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial	N/A
Recruiting	`NCT04736849` - Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury	N/A