What side effects are associated with this type of intervention?

Common treatments for cerebral palsy that involve neuromodulation include botulinum toxin injections, oral medications like anticholinergics and benzodiazepines, and deep brain stimulation (DBS). Botulinum toxin injections can cause transient, mild side effects such as pain at the injection site, muscle weakness, and flu-like symptoms. Oral medications often have a narrow therapeutic window and can lead to side effects like dry mouth, drowsiness, and gastrointestinal issues. Deep brain stimulation, typically reserved for severe cases, may result in complications such as infection, bleeding, or hardware malfunction.

What prior FDA approvals exist?

The FDA has approved several treatments for managing spasticity in Cerebral Palsy, including medications like baclofen, diazepam, and botulinum toxin type A. These treatments primarily focus on reducing muscle stiffness and improving mobility. Neuromodulation techniques, such as intrathecal baclofen pumps, have also been approved and are used to deliver medication directly to the spinal fluid, providing more targeted relief. While specific FDA approvals for Down Conditioning or similar neuromodulation techniques to decrease H Reflex Magnitude in Cerebral Palsy are not detailed, these existing treatments highlight the ongoing efforts to manage spasticity through both pharmacologic and neuromodulation approaches.

What other types of research exist?

Promising novel alternatives to Down Conditioning for CP patients include: 1) Neuromuscular Electrical Stimulation (NMES), which has been shown to improve muscle strength and volume in children with unilateral spastic CP. 2) Self-hypnosis, which has anecdotal evidence suggesting it may help reduce muscle tone in children with spastic CP. 3) Transcutaneous Electrical Nerve Stimulation (TENS), which has been effective in treating chronic pain and could potentially be adapted for spasticity management in CP.

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Behavioral Intervention

Reflex Conditioning for Cerebral Palsy (SRC-CP Trial)

N/A

Recruiting

Led By Kathleen Friel, PhD

Research Sponsored by Burke Medical Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 and above

Diagnosis of spastic Cerebral Palsy

Must not have

History of cardiac conditions

H/O ankle surgeries in affected leg (Dorsal root rhizotomy etc.)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial involves training reflexes to reduce muscle tightness in adults with spastic Cerebral Palsy. The treatment uses exercises to help the body learn to control muscle tightness better. If successful, it could offer a new, non-invasive way to improve movement and daily activities for these patients.

Who is the study for?

Adults over 18 with spastic Cerebral Palsy, able to walk at least 10 meters with or without help. They should be classified as level I-III in motor function and not planning any medication changes for three months. Participants must not be pregnant, have uncontrolled diabetes, skin disorders, heart conditions, latex allergies, recent Botox treatments or surgeries on the affected leg.

What is being tested?

The trial is testing a technique called spinal reflex conditioning on adults with Cerebral Palsy to reduce the H-Reflex magnitude in their muscles. It involves baseline assessments followed by sessions thrice weekly where participants work to decrease this reflex through specific trials.

What are the potential side effects?

Since this intervention involves physical therapy techniques rather than drugs, side effects may include muscle soreness or fatigue from repeated exercises. There's also a small risk of skin irritation from electrodes used during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with spastic Cerebral Palsy.

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I can walk or move with some assistance.

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I can walk 10 meters by myself or with help like a cane.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart conditions.

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I have had surgery on my ankle.

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I have weak muscle movement in my ankle and foot.

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I have not had a seizure since I was 2 years old.

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I am currently taking medication for seizures.

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I have damaged skin, such as wounds, broken skin, or recent scars.

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I regularly use electrical stimulation on my leg muscles.

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My diabetes is not under control.

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I do not have cognitive issues that would prevent me from following the study's procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within one week before the first intervention session to within one week after the end of intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within one week before the first intervention session to within one week after the end of intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and within one week before the first intervention session to within one week after the end of intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Attendance

Soleus H-Reflex size

Secondary study objectives

10 meter walk test

6 minute walk test

Berg Balance Scale

+24 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Spinal reflex conditioningExperimental Treatment1 Intervention

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.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Cerebral Palsy (CP) include physical and occupational therapy, oral antispasticity medications, botulinum toxin injections, and surgical interventions like selective dorsal rhizotomy (SDR). Physical and occupational therapy aim to improve motor function and reduce spasticity through targeted exercises and positioning. Oral medications such as baclofen and benzodiazepines work by reducing muscle tone and spasms through central nervous system depression. Botulinum toxin injections temporarily paralyze overactive muscles by blocking acetylcholine release at the neuromuscular junction. SDR involves cutting selective nerve roots to reduce spasticity. Neuromodulation techniques, like the Down Conditioning trial, aim to decrease the H reflex magnitude, thereby reducing spasticity by altering spinal reflex pathways. These treatments are crucial for CP patients as they help improve mobility, reduce pain, and enhance overall quality of life.

The Most Cited Original Articles in Brain Imaging of Children With Cerebral Palsy: A Bibliometric Analysis Between 1984 and 2019.