Clinical trial NCT04183998: Restorative Neuromodulation for Upper Extremity Functions
Official title: Trans-spinal Electrical Stimulation to Restore Upper Extremity Functions in Individuals With Traumatic Brain Injury (TBI) or Spinal Cord Injury (SCI).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Cervical Spinal Cord Injury
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Hospital Authority, Hong Kong
First posted: 2019-12-03
Enrollment: 2
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this research study is to find the efficacy of trans-spinal electrical stimulation, a non-invasive neurostimulation method to modulate the functions of spinal cord neurocircuits, on improving upper-extremity functions such as reaching and grasping in individuals suffering with traumatic brain injury (TBI) or cervical spinal cord injury (SCI); and to find the physiological changes in the neuromuscular systems after this new intervention with high-resolution electrophysiology and biomedical imaging.

Detailed description: Spinal cord is composed of specialized neural networks, capable of executing different functions. Although the command for upper-limb functions such as reaching and grasping is delivered from the brain, the cervical spinal cord circuits work as an important hub for not only executing the task, but also amplify the command and maintain the dynamics with proper feedback mechanisms with it's reflex circuitry. A simple reaching and grasping function requires spatiotemporal coordination of upper-limb joints and the neuromuscular systems, their adaptation and control in gravity. For human, these physiological activities are well choreographed by sets of neural networks. In combination with afferent sensory inputs, these network circuits work with the motor periphery to generate a series of motor acts during each task. Normally, the activity of these spinal networks are regulated supraspinally and by peripheral sensory inputs. In case of the loss of supraspinal inputs, resultant of a traumatic brain injury (TBI) or cervical spinal cord injury (SCI), upper-limb motor tasks maybe enabled by directly activating these specialized cervical cord networks via external stimuli. Recent studies have demonstrated that neuromodulation via spinal cord stimulation can effectively restore upper-limb motor function in patients with chronic neurological injuries.

Traumatic injuries to the central nervous system (CNS) such as TBI and SCI are devastating events leaving patients with impairment of motor, sensory and autonomic functions. Mainstay for the treatment is still limited to rehabilitation by physical therapy and training. In few patients, however, neuroplasticity and repair mechanisms are considered to contribute to recovery of paresis in the acute stage of the injury and stops in the chronic stage. But, three recent groundbreaking pilot studies have shown that the recovery can be further amplified in the chronic stage by the novel treatment of trans-spinal electrical stimulation. However, the rehabilitation related to this recovery is not well understood, and thus it is a challenge to be convinced with the efficacy of this new therapy. A deeper understanding of the physiology in a larger trial of two different but related neurological patient groups, proposed in this study, will significantly help the researcher to prove the efficacy and understand the mechanism of trans-spinal electrical stimulation therapy for the patients. This study will further assist the researchers to design even a better therapeutic intervention for neurological impaired patients.

Eligibility criteria: Inclusion Criteria:

* At least one year post-injury
* Non-progressive TBI or SCI at above C7 spinal level
* Unable to grip or reach independently, and requires assistance for daily living activities
* Spinal reflexes remain functional below the lesion
* Female participants of child-bearing potential must be on a standard method of contraception and must not be pregnant

Exclusion Criteria:

* Cardiopulmonary disease or dysfunction, high blood pressure or other medical risk factors
* Received Botox injection in the prior 6 months
* Cervical fusion with any metal which may interfere with trans-spinal electric currents
* Other electronic implants such as cardiac pacemakers, defibrillators, shunts, stents etc.
* Unhealed fracture, contracture, pressure sore, or infections
* Currently receiving treatments for either pain management or spasticity or depression

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: 12 months
measure: Modified Ashworth Scale
timeFrame: 12 months
measure: Action Research Arm Test
timeFrame: 12 months
measure: Wolf Motor Function Test
timeFrame: 12
Secondary outcomes:
measure: Functional Independence Measurement
timeFrame: 12 months
Other outcomes:
measure: Electrophysiology
timeFrame: 18 months
Locations:
city: Kowloon
country: Hong Kong
facility: Department of Biomedical Engineering, The Hong Kong Polytechnic University
Study officials:
affiliation: Research Assistant Professor
name: Monzurul Alam, PhD
role: PRINCIPAL_INVESTIGATOR
References: