Back to resultsOperant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy (SRC-CP)
Primary Purpose
Cerebral Palsy, Spastic Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal reflex conditioning
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Hoffman Reflex, Spinal Reflex Conditioning
Eligibility Criteria
For Healthy Volunteers
Inclusion Criteria:
- Age 18 and above
- 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).
Exclusion Criteria:
- 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
- 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
- Skin disorders
- Damaged skin (wounds, broken skin, or recent scar tissue)
- Allergy to latex (tape)
For Adults with Cerebral Palsy
Inclusion Criteria:
- Age 18 and above
- Diagnosis of spastic U/L 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).
Exclusion Criteria:
- 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
- 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)
Sites / Locations
- Burke Neurological InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spinal reflex conditioning
Arm Description
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.
Outcomes
Primary Outcome Measures
Soleus H-Reflex size
Size of h-reflex as measured by EMG
Attendance
Measure of feasibility of protocol, whether or not people can attend all sessions
Secondary Outcome Measures
10 meter walk test
Measure of how long it takes the participant to walk 10 meters
6 minute walk test
Measure the distance a participant can walk in 6 min
Fugl-Meyer
Standardized test of motor skill, range of motion, and spasticity
Modified Ashworth Scale
Measure of muscle spasticity in leg muscles
Range of motion
Measure of flexibility of leg joints
Fatigue Severity Scale
A survey of fatigue symptoms
Berg Balance Scale
Measure of participant's ability to balance
Timed up and Go
Measure of how quickly a participant can stand from a chair, walk, return to chair, and sit
Sit to Stand Test
Time it takes for a participant can stand up five times in a row
Patient Reported Outcome Measures (PROMIS) Anxiety question bank
computer-based survey for participants to answer questions about anxiety
Patient Reported Outcome Measures (PROMIS) Fatigue question bank
computer-based survey for participants to answer questions about fatigue
Patient Reported Outcome Measures (PROMIS) Depression question bank
computer-based survey for participants to answer questions about depression
Patient Reported Outcome Measures (PROMIS) General Life Satisfaction question bank
computer-based survey for participants to answer questions about General Life Satisfaction
Patient Reported Outcome Measures (PROMIS) General Self Efficacy question bank
computer-based survey for participants to answer questions about General Self Efficacy
Patient Reported Outcome Measures (PROMIS) Meaning and Purpose question bank
computer-based survey for participants to answer questions about Meaning and Purpose
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
Patient Reported Outcome Measures (PROMIS) Sleep Disturbances question bank
computer-based survey for participants to answer questions about sleep
Patient Reported Outcome Measures (PROMIS) Pain Interference question bank
computer-based survey for participants to answer questions about pain
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
Patient Reported Outcome Measures (PROMIS) Physical Function
computer-based survey for participants to answer questions about physical functioning
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
Patient Reported Outcome Measures (PROMIS) Mobility question bank
computer-based survey for participants to answer questions about mobility
Patient Reported Outcome Measures (PROMIS) Social Isolation question bank
computer-based survey for participants to answer questions about isolation
Patient Reported Outcome Measures (PROMIS) Upper Extremity question bank
computer-based survey for participants to answer questions about hand and arm function
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
Manual Ability Classification System
A categorical measure of how well a participant can move their hands
Jebsen-Taylor Test of Hand Function
A timed test that measures how quickly the participant can move checkers, cans, and small objects
Full Information
NCT ID
NCT05571033
First Posted
October 2, 2022
Last Updated
September 25, 2023
Sponsor
Burke Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05571033
Brief Title
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
Acronym
SRC-CP
Official Title
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Burke Medical Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic Cerebral Palsy
Keywords
Hoffman Reflex, Spinal Reflex Conditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each participant will serve as their own control.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spinal reflex conditioning
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Spinal reflex conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Soleus H-Reflex size
Description
Size of h-reflex as measured by EMG
Time Frame
Within one week before first intervention session to within one week after the end of intervention
Title
Attendance
Description
Measure of feasibility of protocol, whether or not people can attend all sessions
Time Frame
At the end of the intervention, we will count the number of sessions each participant completed
Secondary Outcome Measure Information:
Title
10 meter walk test
Description
Measure of how long it takes the participant to walk 10 meters
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
6 minute walk test
Description
Measure the distance a participant can walk in 6 min
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Fugl-Meyer
Description
Standardized test of motor skill, range of motion, and spasticity
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Modified Ashworth Scale
Description
Measure of muscle spasticity in leg muscles
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Range of motion
Description
Measure of flexibility of leg joints
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Fatigue Severity Scale
Description
A survey of fatigue symptoms
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Berg Balance Scale
Description
Measure of participant's ability to balance
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Timed up and Go
Description
Measure of how quickly a participant can stand from a chair, walk, return to chair, and sit
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Sit to Stand Test
Description
Time it takes for a participant can stand up five times in a row
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Patient Reported Outcome Measures (PROMIS) Anxiety question bank
Description
computer-based survey for participants to answer questions about anxiety
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Patient Reported Outcome Measures (PROMIS) Fatigue question bank
Description
computer-based survey for participants to answer questions about fatigue
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Patient Reported Outcome Measures (PROMIS) Depression question bank
Description
computer-based survey for participants to answer questions about depression
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Patient Reported Outcome Measures (PROMIS) General Life Satisfaction question bank
Description
computer-based survey for participants to answer questions about General Life Satisfaction
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Patient Reported Outcome Measures (PROMIS) General Self Efficacy question bank
Description
computer-based survey for participants to answer questions about General Self Efficacy
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Patient Reported Outcome Measures (PROMIS) Meaning and Purpose question bank
Description
computer-based survey for participants to answer questions about Meaning and Purpose
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Patient Reported Outcome Measures (PROMIS) Self-Efficacy for Managing Chronic Conditions question bank
Description
computer-based survey for participants to answer questions about Self-Efficacy for Managing Chronic Conditions
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Patient Reported Outcome Measures (PROMIS) Sleep Disturbances question bank
Description
computer-based survey for participants to answer questions about sleep
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Patient Reported Outcome Measures (PROMIS) Pain Interference question bank
Description
computer-based survey for participants to answer questions about pain
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Patient Reported Outcome Measures (PROMIS) Ability to Participate in Social Roles and Activities question bank
Description
computer-based survey for participants to answer questions about Ability to Participate in Social Roles and Activities
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Patient Reported Outcome Measures (PROMIS) Physical Function
Description
computer-based survey for participants to answer questions about physical functioning
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Patient Reported Outcome Measures (PROMIS) Satisfaction with Social Roles and Activities
Description
computer-based survey for participants to answer questions about 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
Title
Patient Reported Outcome Measures (PROMIS) Mobility question bank
Description
computer-based survey for participants to answer questions about mobility
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Patient Reported Outcome Measures (PROMIS) Social Isolation question bank
Description
computer-based survey for participants to answer questions about isolation
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Patient Reported Outcome Measures (PROMIS) Upper Extremity question bank
Description
computer-based survey for participants to answer questions about hand and arm function
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Change in size of motor evoked potential in the brain
Description
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
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Manual Ability Classification System
Description
A categorical measure of how well a participant can move their hands
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Jebsen-Taylor Test of Hand Function
Description
A timed test that measures how quickly the participant can move checkers, cans, and small objects
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Devina Kumar, PhD
Phone
914-368-3160
Email
dek4004@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Friel, PhD
Organizational Affiliation
Burke Neurological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burke Neurological Institute
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Friel, PhD
Phone
914-368-3116
Email
kaf3001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Kathleen Friel, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be available as soon as the findings are published, and will be available indefinitely.
IPD Sharing Access Criteria
We will provide data to researchers who have experience with operant conditioning data analyses.
Citations:
PubMed Identifier
23281107
Citation
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.
Results Reference
background
PubMed Identifier
31166816
Citation
Mrachacz-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.
Results Reference
background
Learn more about this trial
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
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