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

Last updated: September 25, 2023
Sponsor: Burke Medical Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cataplexy

Cerebral Palsy

Treatment

Spinal reflex conditioning

Clinical Study ID

NCT05571033
SRC-CP
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Spinal reflex conditioning
Phase:
Study Start date:
September 30, 2022
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Burke Neurological Institute

    White Plains, New York 10605
    United States

    Active - Recruiting

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