Spinal Cord Injuries Clinical Trial
Official title:
Targeted High-Definition tDCS to Improve Upper Limb Rehabilitation in SCI
The proposed project seeks to maximize the functional recovery achieved during the rehabilitation of the paretic upper limbs in individuals with SCI. The investigation will work towards optimizing the use of transcranial direct current stimulation (tDCS), an adjunct known to improve the effectiveness of rehabilitation. In particular, the relationship between the specificity of current delivery and functional benefit will be explored, and findings may lead to a framework that can be translated to the clinic setting.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | May 23, 2024 |
Est. primary completion date | May 23, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Provision of signed and dated informed consent form - Stated willingness to comply with all study procedures and availability for the duration of the study - Age between 18 and 75 years - Physician diagnosed cervical incomplete spinal cord injury or lesion (iSCI) - Classified by the American Spinal Cord Association (AIS) impairment scale as AIS C or D - iSCI occurred at least 18 months ago - Level of injury or lesion is between C2 and T1 - Bicep strength must be classified as = 3 muscle grade as defined by the medical research council (MRC) scale - Tricep strength must be at least an MRC grade of 2 and be at least 1 muscle grade lower than bicep - Both the biceps and triceps will be required to elicit an active motor evoked potential >200 uV with transcranial magnetic stimulation - Must maintain current medication regime - Must present with a weaker side of the body, as indicated by a Upper Extremity Motor Score (UEMS) score difference between the left and right side - UEMS < 40 (50 max score) Exclusion Criteria: - Pacemaker or other implanted device - Metal in the skull - History of seizures - Pregnancy - First-degree relative with medication-resistant epilepsy - Current participation in upper limb rehabilitation therapies - Current use of illicit drugs, abusing alcohol, or have withdrawn from alcohol in the last 6 months - Other neurological impairment or condition - Pressure ulcers - Significant lower motor neuron loss at C7 as noted by a nerve conduction velocity <50 m/s - History of traumatic brain injury, as documented by Rancho Scale Impairment of = 5 - History of brain MRI documented focal cerebral cortex infarct (e.g. hydrocephalus) - Contractures at the elbow - Severe spasticity as noted by a Modified Ashworth Scale (MAS) > 4. - Documented, non-sedated post-traumatic amnesia lasting more than 48 hours - Demonstrated present gains in motor recovery as noted by a >10% change in triceps strength from pre-test #1 to pre-test #2 - A neuroactive medication that has the potential to lower the seizure threshold |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Rio Grande Valley | Harlingen | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Rio Grande Valley |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) | Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) is a clinical tool that incorporates assessment of both upper limb motor function and activity limitations (9 hole peg test, grasping). The Investigators will assess the changes in movement control from Baseline, 2 weeks, and after four weeks of rehabilitation. An increase in time spent completing the peg test and grasping test signifies an increase in a participant's performance of strength, sensibility, and prehension. | Collected four times during study duration: (Baseline-phase) Day 1 and 14; (Post-Rehabilitation-phase) Day 1 and 14 | |
Primary | Excitability of weak muscle pathways | Using Transcranial Magnetic Stimulation (TMS) to promote Motor Evoked Potentials (MEP), the Investigators will monitor changes in cortical excitability of the weak muscle (Abductor Digiti Minimi; ADM) motor hotspot by measuring the muscle excitability with Electromyography (EMG; in millivolts) from Baseline, 2 weeks, and after four weeks of rehabilitation.
The motor hotspot of the weak muscle will be defined as the site that evokes MEPs =50 mV at the lowest intensity (% device output), or the resting motor threshold (RMT). A decrease of the TMS's percentage output to promote MEPs of the weak muscle signifies a decrease in the cortical excitability, as measured by Active Motor Thresholds (AMT) and Active Motor Evoked Potentials (AMEP). |
Collected four times during study duration: (Baseline-phase) Day 1 and 14; (Post-Rehabilitation-phase) Day 1 and 14 | |
Secondary | Electromyography (EMG) Tracking Accuracy | For the current task, subjects will be asked to match their weak muscle (Abductor Digiti Minimi; ADM) Electromyography (EMG) force to a sine wave with a peak and valley within their strength range displayed on a computer monitor. The investigators will then assess the changes in the subjects' accuracy of matching their EMG force to a sine wave from Baseline, 2-weeks, and after four weeks of rehabilitation. An increase in the variability of a participant keeping their weak muscle EMG force represented as a sine wave within the zone indicates a decrease in performance. | Collected four times during study duration: (Baseline-phase) Day 1 and 14; (Post-Rehabilitation-phase) Day 1 and 14 | |
Secondary | Maximum Volitional Contraction (MVC) | The subjects will be asked to do a maximum contraction of their biceps followed by their triceps, and the investigators will assess the changes in their Maximum Volitional Contraction (MVC; in three trials) using Electromyography (EMG; Root Mean Square in millivolts) from Baseline, 2 weeks, and after four weeks of rehabilitation. A greater number of Root Mean Square millivoltage registered on the EMG signifies a higher MVC. | Collected four times during study duration: (Baseline-phase) Day 1 and 14; (Post-Rehabilitation-phase) Day 1 and 14 |
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