Neuromodulation of the Cortex and Spinal Cord for Cerebral Palsy

This study is investigating how the brain and spinal cord work differently in people with Cerebral Palsy (CP) compared to those without CP. Researchers will use various tests, including brain imaging (fMRI, MEG) and electrical measurements (Hoffmann Reflex Assessments), to understand these differences. They will also explore if applying a gentle electrical current to the brain (cortical stimulation) or spinal cord (spinal cord stimulation) can change this activity. The goal is to better understand the underlying changes in the nervous system in CP and see if these stimulations have an effect. You may be eligible if you are 11 to 45 years old and have Cerebral Palsy with a GMFCS score between I-IV, or if you are a neurotypical control without certain neurodevelopmental conditions. The study aims to measure changes in brain and spinal cord activity, as well as clinical assessments, within one hour.

Study design
This is an interventional study planning to enroll 50 participants. The study type and phase are not specified.
What's involved
You will undergo clinical assessments, brain and spinal cord imaging (fMRI, MEG), Hoffmann Reflex Assessments, and transcutaneous current stimulation (cortical and spinal cord stimulation, including sham).
Compensation
Not stated in the trial record.
Follow-up
Primary outcome measures will be assessed at 1 hour.

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NCT06586437

Neuromodulation of the Cortex and Spinal Cord

Active, Not Recruiting
NAAges 11–45InterventionalTreatment
Father Flanagan's Boys' Home
~50 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Clinical AssessmentsBrain-Spinal Cord fMRIHoffmann Reflex AssessmentsMEG ImagingTranscutaneous Current Stimulation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome Measure-Clinical Assessment
Measured over 1 hour
+4 more outcomes measured
Cerebral Palsy
1 sites across 1 states
Nebraska1
  • Max J Kurz, PhD · PRINCIPAL_INVESTIGATOR · Father Flanagan's Boys' Home

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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:
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
  • Primary Outcome Measure-Clinical Assessment1 hour

    A stimulus intensity will be incrementally increased or decreased from 0.1 to 10 mA as the subject verbally reports their first sensation of the stimulus or perceived loss of the stimulus sensation. The ascending and descending perception tests will be repeated 3 times. The mean of the intensities will be used as the primary outcome variable. The KINARM robot will passively move the participant's hand-arm to various positions in the workspace as they hold the graspable robotic arm. The participant can see the position of their hand as a white dot in the virtual reality display. Once the robot returns home, the participant repeats the same movement that the robot performed. The difference between the final position of the hand when the robot passively moved the participant's arm and the final position when the participant actively moved their arm will be the primary outcome variable.

  • Primary Outcome Measure- fMRI1 hour

    1. Resting State: Functional brain imaging will be performed while the participant looks at a fixation cross for 5 minutes. 2. Brain-Spinal Cord Activity: Functional imaging of the activity in the brain and spinal cord will be acquired concurrently while the participant performs a grip force target matching task. This task will consist of squeezing a force transducer with the hand to animate a box that ascends vertically based on the amount of force applied to the transducer. Target forces will be 10% and 30% of the participant's maximum grip force. The target forces will be randomized. The participant is instructed to match the target forces as quickly and as accurately as possible. The experiment will be conducted separately for the left and right hands and will take 10 minutes each to complete. 3. Spinal Cord Microstructure: Structural images of the spinal cord will be acquired while the participant watches a move. The total scan time will be 20 minutes.

  • Primary Outcome Measure - Hoffman Reflex Assessments1 hour

    A percutaneous nerve stimulation will be used to determine the participant's maximal H-wave (Hmax) of the flexor carpi radialis muscle. This will be determined through 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. Stimulations at the participant's Hmax will be applied as the participants produce a contraction of 10-20% of their maximum voluntary contraction. The participant will be instructed to maintain their EMG activity at the target level for 6.5 seconds as 10 stimulations are delivered at the participants Hmax. The ratio between the mean H-reflex amplitude in the Active Condition and the mean H-reflex amplitude in the Resting Condition will be used as the primary outcome variable. This task will be completed with the non-dominant hand, which will be determined from the clinical assessments.

  • Primary Outcome Measure - MEG Brain Imaging1 hour

    1. Resting state: The participants will sit quietly in the MEG with their eyes closed for 5 minutes. 2. Somatosensory: An electric percutaneous stimulator will be used to deliver a low-level electrical stimulation to the median nerve at a level that is below the motor threshold (i.e., doesn't generate a twitch in the thumb). 3. Isometric Force Matching: Participants will grasp a force transducer that will animate a box vertically to place it inside a target force box that represents 10 and 30% of their maximal grip force. The participants will be instructed to position and hold the animated box inside the target box for 300 ms until the target box disappears. The disappearance of the target box will signify when to stop the sustained force production. Tasks 2 \& 3 will be completed with the non-dominant hand, which will be determined from the clinical assessments.

  • Primary Outcome Measure - Transcutaneous Current Stimulation30 minutes

    For participants receiving transcutaneous current stimulation over the spinal cord, one electrode will be placed over C6 while the other will be placed on the shoulder. Participants will be blinded to if they are in the sham or active group. While receiving the stimulation, the participants will practice opening and closing their less dominant hand for 20 minutes. The less dominant hand will be determined from the clinical assessments performed at the baseline time point. The participant will once again undergo the fMRI, MEG, or H-reflex protocol (which ever they completed for the baseline assessments) after completing the stimulation session. At the end of the transcutaneous current stimulation, the participant will complete a questionnaire regarding the sensations felt during stimulation.