Cerebral PalsyNCT06586437
Neuromodulation of the Cortex and Spinal Cord
A study testing Clinical Assessments, Brain-Spinal Cord fMRI and Hoffmann Reflex Assessments in people with Cerebral Palsy, run by Father Flanagan's Boys' Home at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Clinical Assessments, Brain-Spinal Cord fMRI and Hoffmann Reflex Assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2024to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.)
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boys Town National Research Hospital
Boys Town, Nebraska, 68010
About this study
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.
Read more
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.
Read the detailed description
Cerebral palsy (CP) is the most common pediatric motor disability, affecting 3.6 per 1000 children, and is typically a result of an insult to the developing brain. The brain insult impacts the precision of the motor actions and can have a lifelong impact on the precision of the motor actions. Although these motor deficits are vastly documented clinically, the underlying neurophysiological changes responsible for the emergence of these impairments are less understood. Our experimental work over the past decade has been directed at filling this knowledge gap. For example, magnetoencephalographic (MEG) brain imaging results were the first to show that the sensorimotor cortices of persons with CP exhibit abnormal activity when planning and executing a motor action, and that this aberrant activity is tightly coupled with slower reaction times and muscular force production errors. In addition, the investigators have repeatedly found that persons with CP have uncharacteristic activity within the somatosensory cortices following peripheral stimulation of the foot and hand, and that such abnormal cortical activity persists while producing a motor action. More recently, the investigators have evaluated if the altered cortical activity has cascading effects on the spinal cord interneuron dynamics. The logic for this premise was based on prior animal models that have shown that the initial insult to the developing brain impacts the structural organization of the spinal cord. The investigators\' high-resolution structural MRI pipelines have revealed that the spinal cords of persons with CP have less grey and white matter area notable microstructural aberrations in the lemniscal and corticospinal tracts. Furthermore, the investigators\' neurophysiological tests have indicated that persons with CP cannot excite the spinal cord's higher-threshold type II motor units that govern the fast-twitch fibers and the production of larger muscular forces. Altogether the investigators\' body of experimental work suggests that there are unique interactions between the cortex and spinal cord that are likely responsible for the altered motor actions seen in those with CP. Further investigation of the brain and spinal cord connectivity will be important for advancing our understanding of the neurophysiology of persons with CP and the development of personalized therapeutic approaches that specifically target these deficiencies.
Transcutaneous current stimulation over the cortex and spinal cord is the most common noninvasive stimulation paradigms being explored with persons with CP in the hope of beneficially altering the neural generators that are involved in the production of a motor action. This approach involves the application of stimulating electrodes that emit a low-grade electrical current that passes through the skull/spine/skin to either excite or inhibit the underlying neural generators. The outcomes from these investigations have largely been mixed with some persons with CP demonstrating beneficial improvements, while others are non-responders. There are several limitations of these prior investigations. For one, there have been no neuroimaging investigations that have been performed to determine how the stimulation impacts the neurophysiology of the targeted cortical or spinal cord neural generators of those with CP. Secondarily, none of these prior investigations have considered whether these neuromodulation techniques impact the spinal cord-cortex connectivity. Lastly, many of the initial investigations have been case series that have not included a sham control group. This makes it difficult to discern if the clinical improvements seen in persons with CP after transcutaneous current stimulation are due to the physical therapy or physical therapy plus the neuromodulation.
There are large knowledge gaps in our understanding of how the respective transcutaneous current stimulation approaches influence the neurophysiology of persons with CP and if the stimulation protocols are beneficially altering the neurophysiology. The lion's share of the current research is blindly applying these neuromodulation techniques in hopes of having a beneficial improvement. There is a critical need to robustly evaluate the effect of these neuromodulation techniques on the neurophysiology of those with CP before the investigators are well prepared to launch a clinical trial. The Aims of this investigation are directed at beginning to fill this substantial knowledge gap.
- Conditions
- Cerebral Palsy
- Being tested
- Clinical Assessments, Brain-Spinal Cord fMRI, Hoffmann Reflex Assessments, MEG Imaging, Transcutaneous Current Stimulation
- Keywords
- Cerebral Palsy, Neuromodification, Brain, Spinal Cord, Upper Extremity
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical AssessmentsBehavioural
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 fMRIBehavioural
Resting state, brain-spinal cord activity, spinal cord microstructure, magnetic resonance spectroscopy
Hoffmann Reflex AssessmentsBehavioural
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 ImagingBehavioural
Resting state, somatosensory, isometric force matching, entrainment
Transcutaneous Current StimulationBehavioural
Cortical stimulation, spinal cord stimulation - sham and stim
| Study group | Role | What they receive |
|---|---|---|
| Neurotypical Youth/Adults | Experimental | 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. Receives: Behavioral: Clinical Assessments; Behavioral: Brain-Spinal Cord fMRI; Behavioral: Hoffmann Reflex Assessments; Behavioral: MEG Imaging; Behavioral: Transcutaneous Current Stimulation |
| Cerebral Palsy Youth/Adults | Experimental | 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. Receives: Behavioral: Clinical Assessments; Behavioral: Brain-Spinal Cord fMRI; Behavioral: Hoffmann Reflex Assessments; Behavioral: MEG Imaging; Behavioral: Transcutaneous Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Primary Outcome Measure- fMRI
- Resting State: Functional brain imaging will be performed while the participant looks at a fixation cross for 5 minutes.
- 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.
- 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.
Measured: 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.
Measured: 1 hour
Primary Outcome Measure - MEG Brain Imaging
- Resting state: The participants will sit quietly in the MEG with their eyes closed for 5 minutes.
- 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).
- 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.
Measured: 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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Jan 2024
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cerebral Palsy participants will undergo baseline sham or stim intervention/brain imaging/clinical assessments, and then repeat with opposite intervention. Non-Cerebral Palsy controls will undergo the same baseline testing once as a reference group to determine a normative state of neuromodulation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Father Flanagan's Boys' Home
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Kurz, Father Flanagan's Boys' Home
- Investigators
- Max J Kurz, PhD, Principal investigator, Father Flanagan's Boys' Home
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586437
- Sponsor's protocol ID
- 23-25-XP
- Status last verified
- Jul 2026
- First submitted
- 4 Sep 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation of the Cortex and Spinal Cord
- ClinicalTrials.gov ID
- NCT06586437
- Acronym / sponsor ID
- 23-25-XP
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Neuromodification, Brain, Spinal Cord, Upper Extremity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Father Flanagan's Boys' HomeUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cerebral palsy (CP) is the most common pediatric motor disability, affecting 3.6 per 1000 children, and is typically a result of an insult to the developing brain. The brain insult impacts the precision of the motor actions and can have a lifelong impact on the precision of the motor actions. Although these motor deficits are vastly documented clinically, the underlying neurophysiological changes responsible for the emergence of these impairments are less understood. Our experimental work over the past decade has been directed at filling this knowledge gap. For example, magnetoencephalographic (MEG) brain imaging results were the first to show that the sensorimotor cortices of persons with CP exhibit abnormal activity when planning and executing a motor action, and that this aberrant activity is tightly coupled with slower reaction times and muscular force production errors. In addition, the investigators have repeatedly found that persons with CP have uncharacteristic activity within the somatosensory cortices following peripheral stimulation of the foot and hand, and that such abnormal cortical activity persists while producing a motor action. More recently, the investigators have evaluated if the altered cortical activity has cascading effects on the spinal cord interneuron dynamics. The logic for this premise was based on prior animal models that have shown that the initial insult to the developing brain impacts the structural organization of the spinal cord. The investigators\' high-resolution structural MRI pipelines have revealed that the spinal cords of persons with CP have less grey and white matter area notable microstructural aberrations in the lemniscal and corticospinal tracts. Furthermore, the investigators\' neurophysiological tests have indicated that persons with CP cannot excite the spinal cord's higher-threshold type II motor units that govern the fast-twitch fibers and the production of larger muscular forces. Altogether the investigators\' body of experimental work suggests that there are unique interactions between the cortex and spinal cord that are likely responsible for the altered motor actions seen in those with CP. Further investigation of the brain and spinal cord connectivity will be important for advancing our understanding of the neurophysiology of persons with CP and the development of personalized therapeutic approaches that specifically target these deficiencies.
Transcutaneous current stimulation over the cortex and spinal cord is the most common noninvasive stimulation paradigms being explored with persons with CP in the hope of beneficially altering the neural generators that are involved in the production of a motor action. This approach involves the application of stimulating electrodes that emit a low-grade electrical current that passes through the skull/spine/skin to either excite or inhibit the underlying neural generators. The outcomes from these investigations have largely been mixed with some persons with CP demonstrating beneficial improvements, while others are non-responders. There are several limitations of these prior investigations. For one, there have been no neuroimaging investigations that have been performed to determine how the stimulation impacts the neurophysiology of the targeted cortical or spinal cord neural generators of those with CP. Secondarily, none of these prior investigations have considered whether these neuromodulation techniques impact the spinal cord-cortex connectivity. Lastly, many of the initial investigations have been case series that have not included a sham control group. This makes it difficult to discern if the clinical improvements seen in persons with CP after transcutaneous current stimulation are due to the physical therapy or physical therapy plus the neuromodulation.
There are large knowledge gaps in our understanding of how the respective transcutaneous current stimulation approaches influence the neurophysiology of persons with CP and if the stimulation protocols are beneficially altering the neurophysiology. The lion's share of the current research is blindly applying these neuromodulation techniques in hopes of having a beneficial improvement. There is a critical need to robustly evaluate the effect of these neuromodulation techniques on the neurophysiology of those with CP before the investigators are well prepared to launch a clinical trial. The Aims of this investigation are directed at beginning to fill this substantial knowledge gap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Cerebral Palsy participants will undergo baseline sham or stim intervention/brain imaging/clinical assessments, and then repeat with opposite intervention. Non-Cerebral Palsy controls will undergo the same baseline testing once as a reference group to determine a normative state of neuromodulation.
| Arm | Type | Receives |
|---|---|---|
| Neurotypical Youth/Adults | Experimental | Behavioral: Clinical Assessments, Behavioral: Brain-Spinal Cord fMRI, Behavioral: Hoffmann Reflex Assessments, Behavioral: MEG Imaging, Behavioral: Transcutaneous Current StimulationCompared 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 | Experimental | Behavioral: Clinical Assessments, Behavioral: Brain-Spinal Cord fMRI, Behavioral: Hoffmann Reflex Assessments, Behavioral: MEG Imaging, Behavioral: Transcutaneous Current StimulationCompared 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. |
Who may qualify
- Ages
- 11 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical AssessmentsThe 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 | Behavioural | Cerebral Palsy Youth/Adults, Neurotypical Youth/Adults |
| Brain-Spinal Cord fMRIResting state, brain-spinal cord activity, spinal cord microstructure, magnetic resonance spectroscopy | Behavioural | Cerebral Palsy Youth/Adults, Neurotypical Youth/Adults |
| Hoffmann Reflex AssessmentsHmax 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. | Behavioural | Cerebral Palsy Youth/Adults, Neurotypical Youth/Adults |
| MEG ImagingResting state, somatosensory, isometric force matching, entrainment | Behavioural | Cerebral Palsy Youth/Adults, Neurotypical Youth/Adults |
| Transcutaneous Current StimulationCortical stimulation, spinal cord stimulation - sham and stim | Behavioural | Cerebral Palsy Youth/Adults, Neurotypical Youth/Adults |
Primary outcome
Primary Outcome Measure-Clinical Assessment
Time frame: 1 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- fMRI
Time frame: 1 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 Assessments
Time frame: 1 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 Imaging
Time frame: 1 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 Stimulation
Time frame: 30 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max J Kurz, PhD principal investigator
Father Flanagan's Boys' Home
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Assessments, Brain-Spinal Cord fMRI and Hoffmann Reflex Assessments in people with Cerebral Palsy, run by Father Flanagan's Boys' Home at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure-Clinical Assessment (time frame: 1 hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.