Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Each participant will serve as their own control.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Burke Neurological Institute
White Plains, New York 10605
Contact:
Kathleen Friel, PhD
914-368-3116
kaf3001@med.cornell.edu

More Details

Status
Recruiting
Sponsor
Burke Medical Research Institute

Study Contact

Devina Kumar, PhD
914-368-3160
dek4004@med.cornell.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.