Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy (SRC-CP)

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Spastic Cerebral Palsy
• Intervention / Treatment: Behavioral: Spinal reflex conditioning

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 Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Devina Kumar, PhD; Phone Number: 914-368-3160; Email: dek4004@med.cornell.edu

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 10605
      • Recruiting
      • Burke Neurological Institute
      • Contact: Kathleen Friel, PhD; Phone Number: 914-368-3116; Email: kaf3001@med.cornell.edu
      • Principal Investigator: Kathleen Friel, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 18 and above
2. Diagnosis of spastic Cerebral Palsy
3. Gross Motor Function Classification System level I-III
4. Stable medical background
5. Current medication will remain unchanged for 3 months
6. Provides informed consent
7. can walk at least 10 meters with or without assistive device
8. meets minimum study procedure requirements (elicitation of H-reflex).

Exclusion Criteria:

1. Pregnancy
2. uncontrolled diabetes
3. weak dorsiflexion
4. History of cardiac conditions
5. cognitive deficits that interfere with study procedure and steps for completion
6. Botox within 2 months of the study
7. H/O ankle surgeries in affected leg (Dorsal root rhizotomy etc.)
8. regular use of electrical stimulation to lower extremity muscles
9. Cochlear or metal implantations on body
10. No history of seizure after age 2 years
11. Current use of antiseizure medicines
12. Any metal or magnetic components in the head (surgical clips, metal work etc.)
13. Implanted device or cardiac pacemakers (applicable for DS8R too)
14. Skin disorders
15. Damaged skin (wounds, broken skin, or recent scar tissue)
16. Allergy to latex (tape)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Spinal reflex conditioning; 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.

Behavioral: Spinal reflex conditioning; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soleus H-Reflex size	Size of h-reflex as measured by EMG	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	At the end of the intervention, we will count the number of sessions each participant completed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 meter walk test	Measure of how long it takes the participant to walk 10 meters	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	Within one week before the first intervention session to within one week after the end of intervention

Collaborators and Investigators

• Sponsor: Burke Medical Research Institute
• Investigators: Principal Investigator: Kathleen Friel, PhD, Burke Neurological Institute

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 2, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Hoffman Reflex; Spinal Reflex Conditioning
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: SRC-CP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No