Neuromodulation of the Cortex and Spinal Cord

NCT06586437 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-29

No results posted yet for this study

Summary

Specific Aim 1: To further quantify the difference in the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence of persons with CP.

Overall hypotheses: The sensorimotor cortical activity, spinal cord activity, and corticospinal coherence will be uncharacteristic in persons with CP when compared with neurotypical controls. Furthermore, the extent of the alterations in the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence will be tightly linked with the clinical presentations of persons with CP.

Specific Aim 2: To investigate the effect of transcutaneous current stimulation applied over the cortex and/or spinal cord on the sensorimotor cortical activity, spinal cord dynamics, and corticospinal coherence.

Overall hypotheses: Compared with the sham controls, those receiving the transcutaneous current stimulation will demonstrate alterations in the strength of the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence. Moreover, the extent of the alterations in the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence will be tightly linked with the clinical presentations of persons with CP.

Conditions

  • Cerebral Palsy

Interventions

BEHAVIORAL

Clinical Assessments

The participant will undergo a battery of clinical assessments to identify the upper extremity motor performance, sensory acuity, and ability to complete activities of daily living. Tests 1-5 will be completed separately for each hand. All participants will be video recorded while completing these assessments. The recordings will be used for grading tasks and data analysis: Box and Blocks, 9-hold peg board, Test of Arm Selective Control, Sensory Acuity Testing, KINARM End-Point Lab Sensory Test, Section GG of the inpatient Rehabilitaion Facility-Patient Assessment Instrument, NEURO-QOL Upper Extremity Function Scale, Edinburgh Handed Inventory

BEHAVIORAL

Brain-Spinal Cord fMRI

Resting state, brain-spinal cord activity, spinal cord microstructure, magnetic resonance spectroscopy

BEHAVIORAL

Hoffmann Reflex Assessments

Hmax 20-50 stimulations of increasing intensity. Next, the participant will sit quietly as 10 stimulations will be delivered at the participant's Hmax with an interstimulus interval of 15 seconds. Subsequently, stimulations at the participant's Hmax will be applied as the participants produce a contraction of 10-20% of their maximum voluntary contraction (MVC). The target contraction level will be shown in real-time based on the FCR EMG activity. The participant maintains their EMG activity at the target level for 6.5 seconds as 10 stimulations are delivered at the participants Hmax.

BEHAVIORAL

MEG Imaging

Resting state, somatosensory, isometric force matching, entrainment

BEHAVIORAL

Transcutaneous Current Stimulation

Cortical stimulation, spinal cord stimulation - sham and stim

Sponsors & Collaborators

  • Father Flanagan's Boys' Home

    lead OTHER

Principal Investigators

  • Max J Kurz, PhD · Father Flanagan's Boys' Home

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-17
Primary Completion
2029-08-31
Completion
2029-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06586437 on ClinicalTrials.gov