Restorative Neuromodulation for Upper Extremity Functions

NCT ID: NCT04183998

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2022-01-31

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.

Conditions

Traumatic Brain Injury; Cervical Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tsES

trans-spinal Electrical Stimulation (tsES)

Group Type: EXPERIMENTAL

Trans-spinal Electrical Stimulation (tsES)

Intervention Type: OTHER

Stimulation will be achieved with two self-adhesive stimulation electrodes attached to the dorsal aspect of the neck overlying the cervical vertebrae and two self-adhesive rectangular return electrodes placed over the shoulders. Spinal motor evoked potentials (sMEP) induced by trans-spinal electrical stimulation (parameters, 1 Hz with a 0.1-1 ms pulse width and monophasic waveform) to determine recruitment profiles of proximal and distal motor pools with increasing stimulation intensity ranging from 10 to 200 milliampere. Stimulation parameters for the therapeutic stimulation will be ranged from 5-40 Hz and 20-100 milliampere.

Interventions

Trans-spinal Electrical Stimulation (tsES)

Stimulation will be achieved with two self-adhesive stimulation electrodes attached to the dorsal aspect of the neck overlying the cervical vertebrae and two self-adhesive rectangular return electrodes placed over the shoulders. Spinal motor evoked potentials (sMEP) induced by trans-spinal electrical stimulation (parameters, 1 Hz with a 0.1-1 ms pulse width and monophasic waveform) to determine recruitment profiles of proximal and distal motor pools with increasing stimulation intensity ranging from 10 to 200 milliampere. Stimulation parameters for the therapeutic stimulation will be ranged from 5-40 Hz and 20-100 milliampere.

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr Monzurul Alam

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monzurul Alam, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Assistant Professor

Locations

Department of Biomedical Engineering, The Hong Kong Polytechnic University

Kowloon, , Hong Kong

Countries

Hong Kong

Other Identifiers

HSEARS20190121002

Identifier Type: -

Identifier Source: org_study_id