Restorative Neuromodulation for Upper Extremity Functions

NCT04183998 | Completed

• 1 other identifier: HSEARS20190121002
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Cervical Spinal Cord Injury

Outcome Measures

Primary Outcomes (4)

• Fugl-Meyer Assessment

  Fugl-Meyer Assessment for upper extremity will be used for the measurement of upper limb motor functional recovery. We will adobe the version of the University of Gothenburg approved by Fugl-Meyer AR. In a cumulative numerical scoring to evaluate the physical performance including coordination and speed of the upper extremities, functions of hand and wrist will be assessed separately. The test is constructed with different stages of motor recovery: 1) reflexes reoccur; 2) stereotyped volitional movement can be imitated within flexor and extensor synergies; 3) movements can be performed that deviate from primitive synergies; and 4) reflexes are normalized. A 3-point ordinal scale will be applied to each item: 0=the detail cannot be performed, 1=the detail can be partially performed; 2=the detail can be fully performed. The maximum motor score for the upper extremity can be 66 points where higher score will indicate better function.

  12 months

• Modified Ashworth Scale

  Modified Ashworth Scale is a measurement tool for muscle tone which can be used to measure upper-limb spasticity at different upper extremity segments. It is a 6-point numerical scoring system: 0=no increase in muscle tone, 1=slight increase in muscle tone; 1+=slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder; 2=more marked increase in muscle tone through most of the ROM, but affected part move easily; 3=considerable increase in muscle tone, passive movement difficult; 4=affected part rigid. Lower scores after the treatment will indicate the decrease of muscle spasticity around the specific upper extremity joints, on contrary, higher scores will indicated the aggravation of the muscle spasticity of the segment.The test will be carried out before and after each of the three experimental phases (Phase 1-3).

  12 months

• Action Research Arm Test

  Action Research Arm Test is also a cumulative numerical rating scale for the measurement of upper extremity performance,which is frequently used in research and clinical practice. The reliability of this test has been evaluated in several studies using reliability coefficients such as Spearman's rank correlation coefficient and intra-class correlation coefficient. This test focuses more on the hand functions with 4 basic movements: grasp, grip, pinch and gross movement, and is assessed on a 4-category ordinal scale (i.e., 0,1,2, and 3) with totally 19 items.The ordinal scale is not only related to the degree of completion of an action, but also related to the time cost:0=the motion task cannot be performed, 1=the motion task can be partially performed, 2=the motion task can be fully performed, but clunky or slow, 3=the motion task can be fully performed normally.

  12 months

• Wolf Motor Function Test

  The Wolf Motor Function Test is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks. The Wolf Motor Function Test has been posited as instructive for assessing the motor status of higher functioning chronic patients with stroke and traumatic brain injury, in terms of severity and upper extremity motor deficiency.It has 17 items and is assessed with two scoring systems: 1) a 5-category ordinal scale where higher scores mean better motor function; 2) time counting scale where higher scores mean slower movement and worse motor function.Grip force has also been concluded in this test.

  12

Secondary Outcomes (1)

• Functional Independence Measurement

  12 months

Other Outcomes (1)

• Electrophysiology

  18 months

Study Arms (1)

tsES

EXPERIMENTAL

trans-spinal Electrical Stimulation (tsES)

Other: Trans-spinal Electrical Stimulation (tsES)

Interventions

Trans-spinal Electrical Stimulation (tsES) 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.

tsES

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• University of California, Los Angeles: collaborator
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

Department of Biomedical Engineering, The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Monzurul Alam, PhD

  Research Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: December 3, 2019
• Study Start: May 1, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

HK (1)