Role of Functional Neurosurgery in Management of Spasticity

February 7, 2023 updated by: Ahmed Zanaty, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Spasticity

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate safety and efficacy of neurosurgical procedures
Time Frame: 6 month
Rate of complication ( infection , bleeding , Device Malware )
6 month
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
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Estimate)

February 16, 2023

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neurosurgery and spasticity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Functional Neurological Disorder

Clinical Trials on Intrathecal balofen pump

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe