Role of Functional Neurosurgery in Management of Spasticity

Functional Neurological Disorder Clinical Trial

Official title:

Role of Functional Neurosurgery in Management of Spasticity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05731648
• Other study ID #: Neurosurgery and spasticity
• Status: Not yet recruiting
• Start date: March 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: February 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 1, 2025
• Est. primary completion date: March 1, 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Conversion Disorder
• Functional Neurological Disorder
• Nervous System Diseases

Intervention

Device:
• Intrathecal balofen pump
Management of spasticity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Hinderer SR, Dixon K. Physiologic and clinical monitoring of spastic hypertonia. Phys Med Rehabil Clin N Am. 2001 Nov;12(4):733-46. — View Citation

Kheder A, Nair KP. Spasticity: pathophysiology, evaluation and management. Pract Neurol. 2012 Oct;12(5):289-98. doi: 10.1136/practneurol-2011-000155. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate safety and efficacy of neurosurgical procedures	Rate of complication ( infection , bleeding , Device Malware )	6 month
Primary	Evaluate Changes in Modified Ashworth scale	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	6 month