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Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia

Comparative Study Between the Functional Outcomes of Neuromodulation and Neuroablation Techniques for Treatment of Secondary Dystonia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03347240
Enrollment
120
Registered
2017-11-20
Start date
2013-12-01
Completion date
2016-12-31
Last updated
2017-11-20

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

Conditions

Secondary Dystonia

Brief 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

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.

Interventions

PROCEDUREBrain Lesioning

Stereotactic radiofrequency lesioning of the pallidum or thalamus

PROCEDURECombined anterior and posterior lumbosacral rhizotomy

Combined anterior and posterior lumbosacral rhizotomy

DEVICEDeep brain stimulation

Bilateral DBS

DEVICEIntra-thecal baclofen infusion

Intra-thecal Baclofen infusion

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* secondary dystonia of previous etiologies

Exclusion criteria

* patients who are not candidate for anaesthesia

Design outcomes

Primary

MeasureTime frameDescription
Burke-Fahn-Marsden dystonia rating scale1 yearDystonia rating scale Higher scores means a worse condition of the disease, while low scores indicate a less involvement of the body

Secondary

MeasureTime frameDescription
Modified Ashworth scale1 yearMuscle tone scale
Barthel index1 yearDisability score

Outcome results

None listed

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