Functional Neurological DisorderNCT05731648
Role of Functional Neurosurgery in Management of Spasticity
An observational study of Functional Neurological Disorder, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Neurological Disorder
- What is being tested?
- Intrathecal balofen pump
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Spasticity
Who may be able to join
- Patients with spasticity refractory to medical treatment (most commonly administered oral medications for managing spasticity are diazepam, dantrolene sodium, and baclofen) and physiotherapy
Who cannot join
- Patients unfit for neurosurgical intervention
About this study
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
Read the 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
- Conditions
- Functional Neurological Disorder
- Being tested
- Intrathecal balofen pump
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal balofen pumpDevice
Also called spinal cord stimulator
Management of spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety and efficacy of neurosurgical procedures
Rate of complication ( infection , bleeding , Device Malware )
Measured: 6 month
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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Functional Neurological DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Zanaty, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731648
- Sponsor's protocol ID
- Neurosurgery and spasticity
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hinderer SR, Dixon K. Physiologic and clinical monitoring of spastic hypertonia. Phys Med Rehabil Clin N Am. 2001 Nov;12(4):733-46.
PubMed 11723863Kheder A, Nair KP. Spasticity: pathophysiology, evaluation and management. Pract Neurol. 2012 Oct;12(5):289-98. doi: 10.1136/practneurol-2011-000155.
PubMed 22976059
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Functional Neurosurgery in Management of Spasticity
- ClinicalTrials.gov ID
- NCT05731648
- Acronym / sponsor ID
- Neurosurgery and spasticity
- Conditions
- Functional Neurological Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Spasticity
Key inclusion criteria (1 listed)
- Patients with spasticity refractory to medical treatment (most commonly administered oral medications for managing spasticity are diazepam, dantrolene sodium, and baclofen) and physiotherapy
Key exclusion criteria (1 listed)
- Patients unfit for neurosurgical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal balofen pumpAlso: spinal cord stimulatorManagement of spasticity | Device | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Background: PubMed 11723863Hinderer SR, Dixon K. Physiologic and clinical monitoring of spastic hypertonia. Phys Med Rehabil Clin N Am. 2001 Nov;12(4):733-46.
- Results publication: PubMed 22976059Kheder A, Nair KP. Spasticity: pathophysiology, evaluation and management. Pract Neurol. 2012 Oct;12(5):289-98. doi: 10.1136/practneurol-2011-000155.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Neurological Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety and efficacy of neurosurgical procedures (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05731648, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.