Targeted HD-tDCS to Improve Upper Limb Rehabilitation in SCI

NCT05589415 | Active Not Recruiting

• 1 other identifier: IRB-20-0326
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Keywords

Rehabilitation; Upper Limb; Brain Stimulation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Electromyography (EMG) Tracking Accuracy

  Collected four times during study duration: (Baseline-phase) Day 1 and 14; (Post-Rehabilitation-phase) Day 1 and 14

• Maximum Volitional Contraction (MVC)

  Collected four times during study duration: (Baseline-phase) Day 1 and 14; (Post-Rehabilitation-phase) Day 1 and 14

Study Arms (2)

High Definition tDCS and rehabilitation

EXPERIMENTAL

10 sessions (2 hours/session) will be completed with high definition tDCS and upper limb rehabilitation. Two times prior and two times after rehabilitation, upper limb weakness and neurophysiology will be assessed.

Device: High-definition Transcranial Direct Current Stimulation

Conventional tDCS and rehabilitation

ACTIVE COMPARATOR

10 sessions (2 hours/session) will be completed with conventional tDCS and upper limb rehabilitation. Two times prior and two times after rehabilitation, upper limb weakness and neurophysiology will be assessed.

Device: Conventional Transcranial Direct Current Stimulation

Interventions

High-definition Transcranial Direct Current Stimulation DEVICE

High-definition Transcranial Direct Current Stimulation (HD-tDCS) delivers current through five small electrodes (0.8 cm2) placed in an "X-shaped" configuration via a simple cap. This configuration leads to an 80% greater concentration or focusing of the electric field within the targeted region compared to conventional, non-focal Transcranial Direct Current Stimulation (tDCS). The participant will undergo 30 minutes of treatment at 2 milliamps.

High Definition tDCS and rehabilitation

Conventional Transcranial Direct Current Stimulation DEVICE

Surface electrodes will be placed in saline-soaked sponges (5 x 7 cm2) and applied to different regions of the scalp. The participant will undergo 30 minutes of treatment at 2 milliamps.

Also known as: Transcranial Direct Current Stimulation

Conventional tDCS and rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Rio Grande Valley: lead

Study Sites (1)

University of Texas Rio Grande Valley

Harlingen, Texas, 78550, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Kelsey Baker, PhD

  University of Texas Rio Grande Valley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: October 21, 2022
• Study Start: November 23, 2020
• Primary Completion (Estimated): May 23, 2026
• Study Completion (Estimated): May 23, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)