Secondary DystoniaNCT03347240
Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia
A study testing Brain Lesioning, Combined anterior and posterior lumbosacral rhizotomy and Deep brain stimulation in people with Secondary Dystonia, run by Ain Shams University.
Trial summary
The disability inflected by dystonia encouraged the development of many neurosurgical procedures. This is a prospective study included 120 patients suffering from intractable secondary dystonia. They were subjected to different neurosurgical treatments and were assessed through the follow up period Read more about this study
- Who is it for?
- Ages 3 to 50 years
- Conditions the study is for
- Secondary Dystonia
- What is being tested?
- Brain Lesioning, Combined anterior and posterior lumbosacral rhizotomy and Deep brain stimulation
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2013to 31 Dec 2016
- Phase
- Interventional
- 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 3 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- secondary dystonia of previous etiologies
Who cannot join
- patients who are not candidate for anaesthesia
About this study
Official title: Comparative Study Between the Functional Outcomes of Neuromodulation and Neuroablation Techniques for Treatment of Secondary Dystonia
The disability inflected by dystonia encouraged the development of many neurosurgical procedures.
This is a prospective study included 120 patients suffering from intractable secondary dystonia.
They were subjected to different neurosurgical treatments and were assessed through the follow up period
Read the detailed description
Background:
Secondary dystonia are the syndromes that have dystonic symptoms due to brain insult which can be associated with neonatal encephalopathy syndromes, trauma, vascular injury, infections, demyelinations, or hereditary disorders associated with neurodegenerative process. The disability inflected by dystonia encouraged the development of many neurosurgical procedures in order to improve the quality of life of these patients.
The aim of this study was to compare the outcomes of different Neuroablative and modulation techniques in treatment of secondary dystonia.
Patients and methods This is a prospective study included 120 patients suffering from intractable secondary dystonia. Ablative techniques included the brain lesioning procedure and combined anterior and posterior lumbar rhizotomy (CAPR). Modulation techniques included deep brain stimulation (DBS) and intrathecal baclofen therapy (ITB). Patients with focal dystonia were included in the Botulinum toxin injection group. Patients with generalized dystonia were included in either of the brain lesioning or the deep brain stimulation, and patients with predominant affection of both lower limbs were included in either of the (CAPR) or the (ITB) groups.
Assessment measures included the evaluation of the muscle tone, range of motion, and the Burke-Fahn-Marsden dystonia rating scale through a follow up period of one year.
- Conditions
- Secondary Dystonia
- Being tested
- Brain Lesioning, Combined anterior and posterior lumbosacral rhizotomy, Deep brain stimulation, Intra-thecal baclofen infusion
- Medical subject headings
- Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain LesioningProcedure or surgery
Stereotactic radiofrequency lesioning of the pallidum or thalamus
Combined anterior and posterior lumbosacral rhizotomyProcedure or surgery
Combined anterior and posterior lumbosacral rhizotomy
Deep brain stimulationDevice
Also called DBS
Bilateral DBS
Intra-thecal baclofen infusionDevice
Also called ITB
Intra-thecal Baclofen infusion
| Study group | Role | What they receive |
|---|---|---|
| Brain lesioning group | Active comparator | Stereotactic lesioning of the thalamus or gloves pallidus Receives: Procedure: Brain Lesioning |
| Combined rhizotomy group | Active comparator | Combined anterior and posterior lumbosacral rhizotomy Receives: Procedure: Combined anterior and posterior lumbosacral rhizotomy |
| Deep brain stimulation group | Active comparator | Bilateral globus pallidus internus deep brain stimulation Receives: Device: Deep brain stimulation |
| Intra-thecal Baclofen infusion therapy | Active comparator | Intra-thecal infusion pump Receives: Device: Intra-thecal baclofen infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burke-Fahn-Marsden dystonia rating scale
Dystonia rating scale Higher scores means a worse condition of the disease, while low scores indicate a less involvement of the body
Measured: 1 year
Secondary outcomes (2)
Modified Ashworth scale
Muscle tone scale
Measured: 1 year
Barthel index
Disability score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Dec 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary DystoniaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Nada, Ain Shams University
- Investigators
- Walid A Abdel Ghany, MD, Study director, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347240
- Sponsor's protocol ID
- 4996
- Status last verified
- Nov 2017
- First submitted
- 12 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Functional Outcomes of Neuromodulation and Neuroablation Techniques for Treatment of Secondary Dystonia
- ClinicalTrials.gov ID
- NCT03347240
- Acronym / sponsor ID
- 4996
- Conditions
- Secondary Dystonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 20 Nov 2017 (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.
The disability inflected by dystonia encouraged the development of many neurosurgical procedures.
This is a prospective study included 120 patients suffering from intractable secondary dystonia.
They were subjected to different neurosurgical treatments and were assessed through the follow up period
Detailed description
Background:
Secondary dystonia are the syndromes that have dystonic symptoms due to brain insult which can be associated with neonatal encephalopathy syndromes, trauma, vascular injury, infections, demyelinations, or hereditary disorders associated with neurodegenerative process. The disability inflected by dystonia encouraged the development of many neurosurgical procedures in order to improve the quality of life of these patients.
The aim of this study was to compare the outcomes of different Neuroablative and modulation techniques in treatment of secondary dystonia.
Patients and methods This is a prospective study included 120 patients suffering from intractable secondary dystonia. Ablative techniques included the brain lesioning procedure and combined anterior and posterior lumbar rhizotomy (CAPR). Modulation techniques included deep brain stimulation (DBS) and intrathecal baclofen therapy (ITB). Patients with focal dystonia were included in the Botulinum toxin injection group. Patients with generalized dystonia were included in either of the brain lesioning or the deep brain stimulation, and patients with predominant affection of both lower limbs were included in either of the (CAPR) or the (ITB) groups.
Assessment measures included the evaluation of the muscle tone, range of motion, and the Burke-Fahn-Marsden dystonia rating scale through a follow up period of one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Brain lesioning group | Active comparator | Procedure: Brain LesioningStereotactic lesioning of the thalamus or gloves pallidus |
| Combined rhizotomy group | Active comparator | Procedure: Combined anterior and posterior lumbosacral rhizotomyCombined anterior and posterior lumbosacral rhizotomy |
| Deep brain stimulation group | Active comparator | Device: Deep brain stimulationBilateral globus pallidus internus deep brain stimulation |
| Intra-thecal Baclofen infusion therapy | Active comparator | Device: Intra-thecal baclofen infusionIntra-thecal infusion pump |
Who may qualify
- Ages
- 3 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- secondary dystonia of previous etiologies
Key exclusion criteria (1 listed)
- patients who are not candidate for anaesthesia
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 |
|---|---|---|
| Brain LesioningStereotactic radiofrequency lesioning of the pallidum or thalamus | Procedure or surgery | Brain lesioning group |
| Combined anterior and posterior lumbosacral rhizotomyCombined anterior and posterior lumbosacral rhizotomy | Procedure or surgery | Combined rhizotomy group |
| Deep brain stimulationAlso: DBSBilateral DBS | Device | Deep brain stimulation group |
| Intra-thecal baclofen infusionAlso: ITBIntra-thecal Baclofen infusion | Device | Intra-thecal Baclofen infusion therapy |
Primary outcome
Burke-Fahn-Marsden dystonia rating scale
Time frame: 1 year
Dystonia rating scale Higher scores means a worse condition of the disease, while low scores indicate a less involvement of the body
2 secondary outcomes
Modified Ashworth scale
Time frame: 1 year
Barthel index
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Secondary Dystonia
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Pediatric Disorder, Genetic Predisposition
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Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects
Cerebral Palsy, Dyskinetic, Secondary Dystonia
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Abbott DBS Post-Market Study of Outcomes for Indications Over Time
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Enhancing Sensorimotor Processing in Children With Dystonia
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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.
Walid A Abdel Ghany, MD study director
Associate professor
Questions about this trial
What is this clinical trial studying?
A study testing Brain Lesioning, Combined anterior and posterior lumbosacral rhizotomy and Deep brain stimulation in people with Secondary Dystonia, run by Ain Shams 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: finished, as of the sponsor's last update on 20 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Burke-Fahn-Marsden dystonia rating scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2017.