Spasticity Clinical Trial
Official title:
Functional Magnetic Resonance and Diffusion Tensor Imaging in the Preoperative Assessment of Dystonia
The aim of this study is to evaluate the organization of the motor circuit in a group of patients suffering from dystonia compared with a group of healthy controls. Deep Brain stimulation is a functional neurosurgery technique consisting in neuromodulation of the motor circuit that has been applied to dystonia. The efficiency of this technique depends on the relative preservation of the function and the structure of the motor network . The assessment of neuronal circuit by advanced techniques of functional neuroimaging in this study might contribute to expand our understanding of the abnormalities in motor circuit activation and the integrity of CNS structure underlying dystonia. This study might contribute therefore to the refinement of Deep brain stimulation indications and techniques in complex dystonia syndromes
Advances in the field of functional neurosurgery, neuroradiology and virus neuronal tracing studies have expanded our knowledge of the circuits underlying the clinical expression of several neurologic syndromes. Globus pallidus internus (GPi) Deep brain stimulation (DBS) is a validated technique for the treatment of 'isolated dystonia'. The efficiency of this therapy in 'complex dystonia', commonly associated with focal brain lesions, is limited and heterogeneous. Broadening indications for DBS therapy to complex DDS disorders require further improvement of preoperative assessment of motor circuit functional reorganization and white matter integrity. The efficacy of neuromodulation in these clinical syndromes is determined by the severity of pyramidal involvement, the interactions between cortico-striato-pallido-thalamic and cerebello-thalamo-cortical circuits and motor network reorganization at the cortical level. The aim of the study is to identify movement-related functional magnetic resonance imaging (fMRI) activation patterns in a group of dystonic patients in comparison to healthy controls (HC). Further analysis will assess the recruitment pattern in different patient subgroups defined according to clinical and radiological criteria relevant to GPi DBS eligibility (hyperkinetic/ hypokinetic and prepallidal/ postpallidal). Diffusion tensor imaging (DTI) will be applied to the assessment of the topographic distribution and severity of white matter lesions in the group of dystonic patients in comparison with HC. Further knowledge concerning motor network organization and white matter integrity after focal brain lesions might contribute to the understanding of this mitigated response to DBS and to the refinement of DBS indications and techniques in secondary dystonia ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06150729 -
Study of Intramuscular Injections of OnabotulinumtoxinA to Assess Change in Disease Activity in Pediatric Participants With Spasticity Associated With Cerebral Palsy
|
||
| Completed |
NCT02400619 -
Shockwaves Therapy and Botulinum Toxin for the Treatment of Spasticity in Patients With Cerebral Palsy. A Cross Over RCT
|
Phase 1 | |
| Completed |
NCT01945684 -
A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in Treatment of Post Stroke Upper Limb Spasticity
|
Phase 3 | |
| Completed |
NCT02261142 -
Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS
|
N/A | |
| Completed |
NCT01444794 -
Adult Subjects Suffering From Lower Limb Spasticity Following Stroke
|
||
| Completed |
NCT02334683 -
Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia
|
N/A | |
| Completed |
NCT02170779 -
Developing and Testing a Comprehensive MS Spasticity Management Program
|
Phase 2 | |
| Recruiting |
NCT05674604 -
Cryoneurolysis for Knee and Shoulder Pain in an Inpatient Setting
|
||
| Not yet recruiting |
NCT05926596 -
Leg Stretching Using an Exoskeleton on Demand for People With Spasticity
|
N/A | |
| Terminated |
NCT01712087 -
Long-term Surveillance of the MedStream Programmable Infusion System
|
||
| Completed |
NCT03906305 -
Dry Needling and Bobath Treatment Clinical Effects Focused on Stroke Patients
|
N/A | |
| Completed |
NCT03302741 -
Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface EMG Recordings
|
Phase 4 | |
| Completed |
NCT02291159 -
Effects of DNHS Technique in the Treatment of Upper Limb Spasticity and Function in Stroke
|
N/A | |
| Completed |
NCT01743651 -
Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis
|
Phase 3 | |
| Completed |
NCT01523210 -
DTI Study of the Influence of Physiotherapy on Distribution of BoNT in Spastic Muscle
|
N/A | |
| Completed |
NCT02073513 -
Kinesiotaping the Hand in Cerebral Palsy
|
N/A | |
| Completed |
NCT00607542 -
Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity
|
Phase 1/Phase 2 | |
| Completed |
NCT00702468 -
Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis
|
Phase 3 | |
| Active, not recruiting |
NCT04815967 -
Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity
|
Phase 2/Phase 3 | |
| Completed |
NCT01457352 -
Efficacy and Safety of SPARC0921 in Subjects With Spasticity
|
Phase 3 |