Cerebral PalsySRC-CPNCT05571033
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
A study testing Spinal reflex conditioning in people with Cerebral Palsy and Spastic Cerebral Palsy, run by Burke Medical Research Institute at 1 site in United States.
Trial summary
12 adults with spastic CP will complete 6 baseline sessions and 24 down conditioning sessions held 3 times/week. All clinical and physiological assessments collected at baseline will be reassessed after study completion, and follow ups after 2 weeks, 1 month and 3 months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Spastic Cerebral Palsy
- What is being tested?
- Spinal reflex conditioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 31 Dec 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and above
- Diagnosis of spastic Cerebral Palsy
- Gross Motor Function Classification System level I-III
- Stable medical background
- Current medication will remain unchanged for 3 months
- Provides informed consent
- can walk at least 10 meters with or without assistive device
- meets minimum study procedure requirements (elicitation of H-reflex).
Who cannot join
- Pregnancy
- uncontrolled diabetes
- weak dorsiflexion
- History of cardiac conditions
- cognitive deficits that interfere with study procedure and steps for completion
- Botox within 2 months of the study
Show all 16Show fewer
- H/O ankle surgeries in affected leg (Dorsal root rhizotomy etc.)
- regular use of electrical stimulation to lower extremity muscles
- Cochlear or metal implantations on body
- No history of seizure after age 2 years
- Current use of antiseizure medicines
- Any metal or magnetic components in the head (surgical clips, metal work etc.)
- Implanted device or cardiac pacemakers (applicable for DS8R too)
- Skin disorders
- Damaged skin (wounds, broken skin, or recent scar tissue)
- Allergy to latex (tape)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Burke Neurological Institute
White Plains, New York, 10605
Kathleen Friel, PhD, 914-368-3116, kaf3001@med.cornell.edu
Kathleen Friel, PhD
About this study
12 adults with spastic CP will complete 6 baseline sessions and 24 down conditioning sessions held 3 times/week. All clinical and physiological assessments collected at baseline will be reassessed after study completion, and follow ups after 2 weeks, 1 month and 3 months. The soleus H reflex (electric analogue of the stretch reflex) will be elicited in all sessions. In each session, participants will complete 20 baseline trials and 225 down conditioning trials to decrease the magnitude of the H-Reflex.
Read the detailed description
Individuals with CP face significant challenges due to spasticity that causes activity and participation restrictions with increase in secondary conditions. This is caused by injury to the upper motor neurons causing disruption to the neural circuitry responsible for maintaining motor tone. A novel intervention, OC of the H reflex has shown promising effects to reduce spasticity and improve motor function in people with stroke and spinal cord. Its many known benefits include easy administration, non-invasive technique, no side effects, and long-term retention. In the study, the investigators will attempt to decrease the increased muscle tone of individuals with CP. If successful, it will not only provide evidence for future clinical application but also broaden the scope for alternate or supplementary non-invasive treatment approaches to decrease spasticity.
- Conditions
- Cerebral Palsy, Spastic Cerebral Palsy
- Being tested
- Spinal reflex conditioning
- Keywords
- Hoffman Reflex, Spinal Reflex Conditioning
- Medical subject headings
- Cerebral Palsy, Reflex, Abnormal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal reflex conditioningBehavioural
Each participant will serve as their own control. The intervention is 30 sessions. The first 6 sessions are baseline measures of reflexes. The remaining sessions will engage participants in learning how to decrease their reflex activity in their calf muscle on the more-affected leg. Each intervention visit will involve 20 trials in which participants do not get visual feedback about their performance, then 225 trials with visual feedback.
| Study group | Role | What they receive |
|---|---|---|
| Spinal reflex conditioning | Experimental | The OC intervention includes 6 baseline sessions and 24 conditioning/ no conditioning sessions held 3 times/week.
To elicit an H-reflex, participants will be asked to stand in a comfortable position. Small pulses of energy will be applied to a nerve in the leg called the tibial nerve. We will record when the participant maintains leg muscle activity. During the intervention, participants will be trained to decrease their reflex in their calf. Receives: Behavioral: Spinal reflex conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soleus H-Reflex size
Size of h-reflex as measured by EMG
Measured: Within one week before first intervention session to within one week after the end of intervention
Attendance
Measure of feasibility of protocol, whether or not people can attend all sessions
Measured: At the end of the intervention, we will count the number of sessions each participant completed
Secondary outcomes (27)
10 meter walk test
Measure of how long it takes the participant to walk 10 meters
Measured: Within one week before the first intervention session to within one week after the end of intervention
6 minute walk test
Measure the distance a participant can walk in 6 min
Measured: Within one week before the first intervention session to within one week after the end of intervention
Fugl-Meyer
Standardized test of motor skill, range of motion, and spasticity
Measured: Within one week before the first intervention session to within one week after the end of intervention
Modified Ashworth Scale
Measure of muscle spasticity in leg muscles
Measured: Within one week before the first intervention session to within one week after the end of intervention
Range of motion
Measure of flexibility of leg joints
Measured: Within one week before the first intervention session to within one week after the end of intervention
Fatigue Severity Scale
A survey of fatigue symptoms
Measured: Within one week before the first intervention session to within one week after the end of intervention
Berg Balance Scale
Measure of participant's ability to balance
Measured: Within one week before the first intervention session to within one week after the end of intervention
Timed up and Go
Measure of how quickly a participant can stand from a chair, walk, return to chair, and sit
Measured: Within one week before the first intervention session to within one week after the end of intervention
Sit to Stand Test
Time it takes for a participant can stand up five times in a row
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Anxiety question bank
computer-based survey for participants to answer questions about anxiety
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Fatigue question bank
computer-based survey for participants to answer questions about fatigue
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Depression question bank
computer-based survey for participants to answer questions about depression
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) General Life Satisfaction question bank
computer-based survey for participants to answer questions about General Life Satisfaction
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) General Self Efficacy question bank
computer-based survey for participants to answer questions about General Self Efficacy
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Meaning and Purpose question bank
computer-based survey for participants to answer questions about Meaning and Purpose
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Self-Efficacy for Managing Chronic Conditions question bank
computer-based survey for participants to answer questions about Self-Efficacy for Managing Chronic Conditions
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Sleep Disturbances question bank
computer-based survey for participants to answer questions about sleep
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Pain Interference question bank
computer-based survey for participants to answer questions about pain
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Ability to Participate in Social Roles and Activities question bank
computer-based survey for participants to answer questions about Ability to Participate in Social Roles and Activities
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Physical Function
computer-based survey for participants to answer questions about physical functioning
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Satisfaction with Social Roles and Activities
computer-based survey for participants to answer questions about Satisfaction with Social Roles and Activities
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Mobility question bank
computer-based survey for participants to answer questions about mobility
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Social Isolation question bank
computer-based survey for participants to answer questions about isolation
Measured: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Upper Extremity question bank
computer-based survey for participants to answer questions about hand and arm function
Measured: Within one week before the first intervention session to within one week after the end of intervention
Change in size of motor evoked potential in the brain
Using single pulse transcranial magnetic stimulation, we will measure the amount of energy required to evoke a leg muscle movement from a stimulus delivered to the head
Measured: Within one week before the first intervention session to within one week after the end of intervention
Manual Ability Classification System
A categorical measure of how well a participant can move their hands
Measured: Within one week before the first intervention session to within one week after the end of intervention
Jebsen-Taylor Test of Hand Function
A timed test that measures how quickly the participant can move checkers, cans, and small objects
Measured: Within one week before the first intervention session to within one week after the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start30 Sep 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will serve as their own control.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burke Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Friel, PhD, Principal investigator, Burke Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571033
- Sponsor's protocol ID
- SRC-CP
- Acronym
- SRC-CP
- Status last verified
- Sep 2023
- First submitted
- 2 Oct 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will email deidentified datasets to other researchers upon request. When we publish our results, we will mention in the paper(s) that the dataset is fully available via email.
Publications
Thompson AK, Chen XY, Wolpaw JR. Soleus H-reflex operant conditioning changes the H-reflex recruitment curve. Muscle Nerve. 2013 Apr;47(4):539-44. doi: 10.1002/mus.23620. Epub 2012 Dec 21.
PubMed 23281107Mrachacz-Kersting N, Kersting UG, de Brito Silva P, Makihara Y, Arendt-Nielsen L, Sinkjaer T, Thompson AK. Acquisition of a simple motor skill: task-dependent adaptation and long-term changes in the human soleus stretch reflex. J Neurophysiol. 2019 Jul 1;122(1):435-446. doi: 10.1152/jn.00211.2019. Epub 2019 Jun 5.
PubMed 31166816
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05571033
- Acronym / sponsor ID
- SRC-CP / SRC-CP
- Conditions
- Cerebral Palsy, Spastic Cerebral Palsy
- Keywords
- Hoffman Reflex, Spinal Reflex Conditioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Burke Medical Research InstituteUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Oct 2022 (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.
12 adults with spastic CP will complete 6 baseline sessions and 24 down conditioning sessions held 3 times/week. All clinical and physiological assessments collected at baseline will be reassessed after study completion, and follow ups after 2 weeks, 1 month and 3 months. The soleus H reflex (electric analogue of the stretch reflex) will be elicited in all sessions. In each session, participants will complete 20 baseline trials and 225 down conditioning trials to decrease the magnitude of the H-Reflex.
Detailed description
Individuals with CP face significant challenges due to spasticity that causes activity and participation restrictions with increase in secondary conditions. This is caused by injury to the upper motor neurons causing disruption to the neural circuitry responsible for maintaining motor tone. A novel intervention, OC of the H reflex has shown promising effects to reduce spasticity and improve motor function in people with stroke and spinal cord. Its many known benefits include easy administration, non-invasive technique, no side effects, and long-term retention. In the study, the investigators will attempt to decrease the increased muscle tone of individuals with CP. If successful, it will not only provide evidence for future clinical application but also broaden the scope for alternate or supplementary non-invasive treatment approaches to decrease spasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Spinal reflex conditioning | Experimental | Behavioral: Spinal reflex conditioningThe OC intervention includes 6 baseline sessions and 24 conditioning/ no conditioning sessions held 3 times/week. To elicit an H-reflex, participants will be asked to stand in a comfortable position. Small pulses of energy will be applied to a nerve in the leg called the tibial nerve. We will record when the participant maintains leg muscle activity. During the intervention, participants will be trained to decrease their reflex in their calf. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 and above
- Diagnosis of spastic Cerebral Palsy
- Gross Motor Function Classification System level I-III
- Stable medical background
- Current medication will remain unchanged for 3 months
Key exclusion criteria (16 listed)
- Pregnancy
- uncontrolled diabetes
- weak dorsiflexion
- History of cardiac conditions
- cognitive deficits that interfere with study procedure and steps for completion
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 |
|---|---|---|
| Spinal reflex conditioningEach participant will serve as their own control. The intervention is 30 sessions. The first 6 sessions are baseline measures of reflexes. The remaining sessions will engage participants in learning how to decrease their reflex activity in their calf muscle on the more-affected leg. Each intervention visit will involve 20 trials in which participants do not get visual feedback about their performance, then 225 trials with visual feedback. | Behavioural | Spinal reflex conditioning |
Primary outcome
Soleus H-Reflex size
Time frame: Within one week before first intervention session to within one week after the end of intervention
Size of h-reflex as measured by EMG
Attendance
Time frame: At the end of the intervention, we will count the number of sessions each participant completed
Measure of feasibility of protocol, whether or not people can attend all sessions
27 secondary outcomes
10 meter walk test
Time frame: Within one week before the first intervention session to within one week after the end of intervention
6 minute walk test
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Fugl-Meyer
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Modified Ashworth Scale
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Range of motion
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Fatigue Severity Scale
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Berg Balance Scale
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Timed up and Go
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Sit to Stand Test
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Anxiety question bank
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Fatigue question bank
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Depression question bank
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) General Life Satisfaction question bank
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) General Self Efficacy question bank
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Meaning and Purpose question bank
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Self-Efficacy for Managing Chronic Conditions question bank
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Sleep Disturbances question bank
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Pain Interference question bank
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Ability to Participate in Social Roles and Activities question bank
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Physical Function
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Satisfaction with Social Roles and Activities
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Mobility question bank
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Social Isolation question bank
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Patient Reported Outcome Measures (PROMIS) Upper Extremity question bank
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Change in size of motor evoked potential in the brain
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Manual Ability Classification System
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Jebsen-Taylor Test of Hand Function
Time frame: Within one week before the first intervention session to within one week after the end of intervention
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 26 Sep 2023.
- Background: PubMed 23281107Thompson AK, Chen XY, Wolpaw JR. Soleus H-reflex operant conditioning changes the H-reflex recruitment curve. Muscle Nerve. 2013 Apr;47(4):539-44. doi: 10.1002/mus.23620. Epub 2012 Dec 21.
- Background: PubMed 31166816Mrachacz-Kersting N, Kersting UG, de Brito Silva P, Makihara Y, Arendt-Nielsen L, Sinkjaer T, Thompson AK. Acquisition of a simple motor skill: task-dependent adaptation and long-term changes in the human soleus stretch reflex. J Neurophysiol. 2019 Jul 1;122(1):435-446. doi: 10.1152/jn.00211.2019. Epub 2019 Jun 5.
- Individual participant dataSharing planned: Yes. We will email deidentified datasets to other researchers upon request. When we publish our results, we will mention in the paper(s) that the dataset is fully available via email.
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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.
Kathleen Friel, PhD principal investigator
Burke Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal reflex conditioning in people with Cerebral Palsy and Spastic Cerebral Palsy, run by Burke Medical Research Institute 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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 26 Sep 2023. 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?
Contact Devina Kumar, PhD (914-368-3160, dek4004@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soleus H-Reflex size (time frame: Within one week before first intervention session to within one week after the end of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05571033, which also lists 2 linked publications.
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 26 Sep 2023.