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Role of Functional Neurosurgery in Management of Spasticity

Role of Functional Neurosurgery in Management of Spasticity

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05731648
Enrollment
40
Registered
2023-02-16
Start date
2023-03-01
Completion date
2025-04-01
Last updated
2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Neurological Disorder

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

Interventions

DEVICEIntrathecal balofen pump

Management of spasticity

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate safety and efficacy of neurosurgical procedures6 monthRate of complication ( infection , bleeding , Device Malware )
Evaluate Changes in Modified Ashworth scale6 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026