Phase 2 N=41 Randomized Quadruple-blind Treatment

Improving SCI Rehabilitation Interventions by Retraining the Brain

Cervical Spinal Cord Injruy

Bottom Line

View on ClinicalTrials.gov: NCT03892746 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2025

Primary outcome: Primary: Change in Upper Extremity Motor Score (UEMS) With Manual Muscle Testing — 3.5; 2.55 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Active tDCS + task oriented practice (Device); Sham tDCS + task oriented practice (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Sep 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Upper Extremity Motor Score (UEMS) With Manual Muscle Testing	3.5; 2.55	—
PRIMARY Change in Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)	9.56; 10.3	—
PRIMARY Change in Canadian Occupational Performance Measure (COPM) Performance	0.89; 0.77	—
PRIMARY Change in Canadian Occupational Performance Measure (COPM) Satisfaction	0.92; 1.36	—
PRIMARY Change in Spinal Cord Independence Measure (SCIM), Self-care Subscore	0.62; 0.3	—
PRIMARY Change in Capabilities of Upper Extremity Test (CUE-T)	3.44; 3.75	—
PRIMARY Change in Excitability (Active Motor Threshold) of Cortical and Corticospinal Physiology (TMS), Weaker Arm-Biceps	1.1; -0.9	—
PRIMARY Change in Excitability (Active Motor Threshold) of Cortical and Corticospinal Physiology (TMS), Weaker Arm Triceps	0.1; -2.2	—
PRIMARY Change in Excitability of Spinal Physiology of the Flexor Carpi Radialis Muslce in the Weaker Arm.	-5.1; -0.7	—

Summary

The Long-term goal of this project is to develop upper limb rehabilitation interventions that can be utilized for cervical Spinal Cord Injury survivors. This Study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 15 sessions over several weeks up to 8 weeks. The Study will include the following site visits: * Eligibility Screening and Informed Consent Visit. * Four testing visit in which motor function of the upper limb and neurophysiology will be measured * Fifteen intervention visits during which patients will receive upper limb training in conjunction with non-invasive brain stimulation * Repeat testing of motor function and neurophysiology of the upper limb following completion of intervention visits * a Follow-up visit completed 3 months after the completion of interventions

Eligibility Criteria

Inclusion Criteria

Patients with incomplete (having sparing to muscles in the upper extremities below the level of injury) C1-C8 SCI
at least 1 year post injury
weakness of the triceps or biceps muscle in the weaker upper limb, defined as a clinically detectable difference in power compared to the power of the spared antagonist(biceps and triceps respectively) muscle, i.e., at least one muscle grade lower on the MRC scale.

Exclusion Criteria

contraindications to tDCS and TMS including: pacemaker, metal in the skull, seizure history, pregnancy.
pressure ulcers
traumatic brain injury (TBI), diagnosed based upon acute injury Rancho scale <5 or positive MRI/CT findings at the time of injury will also be excluded to prevent confounding of TMS metrics.
excessive tone/spasticity and severe contractures or soft tissue shortening at the elbow/wrist
participating in ongoing upper-limb therapies

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03892746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.