Role of Functional Neurosurgery in Management of Spasticity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 40
- Primary Endpoint
- Evaluate safety and efficacy of neurosurgical procedures
Study Overview
Brief Summary
Spasticity can result from a variety of causes in neural axis from which most common are cerebral palsy, strokes, cerebral haemorrhage, multiple sclerosis , traumatic brain injury and spinal cord injury and underlying mechanism is broadly due to decrease inhibition of the spinal network.
Clinical evaluation for spasticity involve series of clinical assessment , physical examination , and neurophysiological testing. quantitative evaluation of spasticity can be measured using modified Ashworth scale which is the most widely used clinical spasticity scale and can be used for various clinical conditions causing spasticity
Detailed Description
Currently, the management of spasticity spans in a continuum between non-invasive and invasive intervention to modulate its effects and improve patients' Quality of life and when spasticity becomes excessive and aggravates disability, functional neurosurgery can be a resource.
Neurosurgical procedures for management of spasticity are classified according to whether their effect is generalized or focal and whether they are reversible or irreversible. Procedures include intrathecal baclofen pump , spinal cord stimulation and lesioning techniques peripheral nerves , dorsal roots , spinal cord or dorsal root entry zone
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with spasticity refractory to medical treatment (most commonly administered oral medications for managing spasticity are diazepam, dantrolene sodium, and baclofen) and physiotherapy
Exclusion Criteria
- •Patients unfit for neurosurgical intervention
Outcomes
Primary Outcomes
Evaluate safety and efficacy of neurosurgical procedures
Time Frame: 6 month
Rate of complication ( infection , bleeding , Device Malware )
Evaluate Changes in Modified Ashworth scale
Time Frame: 6 month
* 0: No increase in muscle tone * 1: Slight increase in muscle tone, with a catch and release or minimal resistance at the end of the range of motion when an affected part(s) is moved in flexion or extension * 1+: Slight increase in muscle tone, manifested as a catch, followed by minimal resistance through the remainder (less than half) of the range of motion * 2: A marked increase in muscle tone throughout most of the range of motion, but affected part(s) are still easily moved * 3: Considerable increase in muscle tone, passive movement difficult * 4: Affected part(s) rigid in flexion or extension
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmed Zanaty
Assistant lecturer
Assiut University