Neuromodulation of the Cortex and Spinal Cord
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2024
CompletedFirst Submitted
Initial submission to the registry
September 4, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
September 29, 2025
September 1, 2025
5.5 years
September 4, 2024
September 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Primary Outcome Measure-Clinical Assessment
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.
1 hour
Primary Outcome Measure- fMRI
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.
1 hour
Primary Outcome Measure - Hoffman Reflex Assessments
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.
1 hour
Primary Outcome Measure - MEG Brain Imaging
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.
1 hour
Primary Outcome Measure - Transcutaneous Current Stimulation
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.
30 minutes
Study Arms (2)
Neurotypical Youth/Adults
EXPERIMENTALCompared 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.
Cerebral Palsy Youth/Adults
EXPERIMENTALCompared 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.
Interventions
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
Resting state, brain-spinal cord activity, spinal cord microstructure, magnetic resonance spectroscopy
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.
Resting state, somatosensory, isometric force matching, entrainment
Cortical stimulation, spinal cord stimulation - sham and stim
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boys Town National Research Hospital
Boys Town, Nebraska, 68010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Max J Kurz, PhD
Father Flanagan's Boys' Home
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of PoWER Lab
Study Record Dates
First Submitted
September 4, 2024
First Posted
September 19, 2024
Study Start
January 17, 2024
Primary Completion (Estimated)
August 1, 2029
Study Completion (Estimated)
August 1, 2029
Last Updated
September 29, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Upon completion of study and data analysis
- Access Criteria
- Contact Dr. Kurz
The PI and all of the investigators have made a commitment to publish, in a timely manner, all of the relevant scientific information that they will derive during this project. Deidentified data will be made available upon reasonable request to the Principal Investigator (Dr. Kurz).