RecruitingNot ApplicableNCT06586437

Neuromodulation of the Cortex and Spinal Cord


Sponsor

Father Flanagan's Boys' Home

Enrollment

50 participants

Start Date

Jan 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 11 YearsMax Age: 45 Years

Inclusion Criteria4

  • For Cerebral Palsy Participants:
  • Gross Motor Function Classification score (GMFCS) levels between I-IV
  • For Neurotypical Controls:
  • No known atypical neurodevelopment (e.g. autism, Down Syndrome, ADHD, etc.)

Exclusion Criteria10

  • For Cerebral Palsy Participants:
  • Pregnancy
  • Any condition that, in the opinion of the investigator, is a contraindication to participation
  • The presence of any ferrous metal implant, including orthodonture, which may interfere with the MEG data acquisition and/or be an MRI safety concern
  • No orthopedic surgery in the last 6 months or metal in their body that would preclude the use of an MRI
  • For Neurotypical Controls:
  • Pregnancy
  • Any condition that, in the opinion of the investigator, is a contraindication to participation
  • The presence of any ferrous metal implant, including orthodonture, which may interfere with the MEG data acquisition and/or be an MRI safety concern
  • No orthopedic surgery in the last 6 months or metal in their body that would preclude the use of an MRI

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Interventions

BEHAVIORALClinical 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

BEHAVIORALBrain-Spinal Cord fMRI

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

BEHAVIORALHoffmann 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.

BEHAVIORALMEG Imaging

Resting state, somatosensory, isometric force matching, entrainment

BEHAVIORALTranscutaneous Current Stimulation

Cortical stimulation, spinal cord stimulation - sham and stim


Locations(1)

Boys Town National Research Hospital

Boys Town, Nebraska, United States

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NCT06586437


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