Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy

NCT05571033 | Recruiting

• 1 other identifier: SRC-CP
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Spastic Cerebral Palsy

Keywords

Hoffman Reflex; Spinal Reflex Conditioning

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (27)

• 10 meter walk test

  Within one week before the first intervention session to within one week after the end of intervention

• 6 minute walk test

  Within one week before the first intervention session to within one week after the end of intervention

• Fugl-Meyer

  Within one week before the first intervention session to within one week after the end of intervention

• Modified Ashworth Scale

  Within one week before the first intervention session to within one week after the end of intervention

• Range of motion

  Within one week before the first intervention session to within one week after the end of intervention

Study Arms (1)

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.

Behavioral: Spinal reflex conditioning

Interventions

Spinal reflex conditioning BEHAVIORAL

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.

Spinal reflex conditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Burke Medical Research Institute: lead

Study Sites (1)

Burke Neurological Institute

White Plains, New York, 10605, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 23281107 BACKGROUND

• 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.

  PMID: 31166816 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Reflex, Abnormal

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathleen Friel, PhD

  Burke Neurological Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Devina Kumar, PhD

CONTACT

914-368-3160; dek4004@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will serve as their own control.

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: October 7, 2022
• Study Start: September 30, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available as soon as the findings are published, and will be available indefinitely.
• Access Criteria: We will provide data to researchers who have experience with operant conditioning data analyses.

Locations

US (1)