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

NCT ID: NCT05571033

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2026-12-31

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.

Conditions

Cerebral Palsy; Spastic Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Spinal reflex conditioning

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Burke Medical Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen Friel, PhD

Role: PRINCIPAL_INVESTIGATOR

Burke Neurological Institute

Locations

Burke Neurological Institute

White Plains, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Devina Kumar, PhD

Role: CONTACT

dek4004@med.cornell.edu

914-368-3160

Facility Contacts

Kathleen Friel, PhD

Role: primary

kaf3001@med.cornell.edu

914-368-3116

References

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.

Reference Type: BACKGROUND

PMID: 23281107 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31166816 (View on PubMed)

Other Identifiers

SRC-CP

Identifier Type: -

Identifier Source: org_study_id