Neuromodulation of the Cortex and Spinal Cord

Part of paid clinical trials in Boys Town, Nebraska.

Sponsor
Father Flanagan's Boys' Home
Study ID
NCT06586437
Status
Recruiting
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Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
11 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Clinical Assessments — BEHAVIORAL
    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
  • Brain-Spinal Cord fMRI — BEHAVIORAL
    Resting state, brain-spinal cord activity, spinal cord microstructure, magnetic resonance spectroscopy
  • Hoffmann Reflex Assessments — BEHAVIORAL
    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.
  • MEG Imaging — BEHAVIORAL
    Resting state, somatosensory, isometric force matching, entrainment
  • Transcutaneous Current Stimulation — BEHAVIORAL
    Cortical stimulation, spinal cord stimulation - sham and stim

Study Details

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.

Key Dates

Start date
Jan 17, 2024
Status verified
Sep 2025
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neurotypical Youth/Adults
    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.
  • Experimental: Cerebral Palsy Youth/Adults
    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 controls.

Primary Outcome Measure

Primary Outcome Measure-Clinical Assessment [ Time Frame: 1 hour ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boys Town National Research HospitalBoys TownNebraska68010
Max J Kime, PhD
[email protected]
402-559-3415
Jennifer M Kime, MS
[email protected]
531-355-8959
Max J Kurz, PhD (PRINCIPAL_INVESTIGATOR)

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Boys Town National Research Hospital· Boys Town, NE

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