Clinical trial NCT05571033: Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
Official title: Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Spastic Cerebral Palsy
Keywords: Hoffman Reflex
Spinal Reflex Conditioning
Lead sponsor: Burke Medical Research Institute
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant will serve as their own control.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Soleus H-Reflex size
timeFrame: Within one week before first intervention session to within one week after the end of intervention
measure: Attendance
timeFrame: At the end of the intervention, we will count the number of sessions each participant completed
Secondary outcomes:
measure: 10 meter walk test
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: 6 minute walk test
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Fugl-Meyer
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Modified Ashworth Scale
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Range of motion
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Fatigue Severity Scale
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Berg Balance Scale
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Timed up and Go
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Sit to Stand Test
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) Anxiety question bank
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) Fatigue question bank
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) Depression question bank
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) General Life Satisfaction question bank
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) General Self Efficacy question bank
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) Meaning and Purpose question bank
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) Self-Efficacy for Managing Chronic Conditions question bank
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) Sleep Disturbances question bank
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) Pain Interference question bank
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) Ability to Participate in Social Roles and Activities question bank
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) Physical Function
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) Satisfaction with Social Roles and Activities
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) Mobility question bank
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) Social Isolation question bank
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Patient Reported Outcome Measures (PROMIS) Upper Extremity question bank
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Change in size of motor evoked potential in the brain
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Manual Ability Classification System
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Jebsen-Taylor Test of Hand Function
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke Neurological Institute
state: New York
Study officials:
affiliation: Burke Neurological Institute
name: Kathleen Friel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.