Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness - Full Text View

Sponsors and Collaborators:	University Hospital, Clermont-Ferrand Medtronic
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00505323

Purpose

Dystonia is a neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. This disease is very heterogeneous and can have many causes. Current treatments (drugs, pallidal stimulation) improve primary generalized dystonias; however they are ineffective for focal dystonias following brain damage. Cortex stimulation is a present and effective technique used in the treatment of chronic pain and could represent an interesting strategy to treat focal dystonias. This is the aim of the present study.

Condition	Intervention	Phase
Focal Dystonia	Device: Implantation of neurostimulators and their auxiliary components	Phase I

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Crossover Assignment, Efficacy Study

Official Title:

Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Pallidal Lesion :

Evaluation of Safety and Effectiveness

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Dystonia

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

Evaluation of dystonia by using the validated "Burke Fahn and Marsden (1985)" dystonia rating scale [ Time Frame: before the chirurgical intervention and 2, 5, 6, 9 and 13 months after ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluation of spasticity (Ashworth), of akinesy (Tapping score), of pain (EVA test), of quality of life (SF 36 scale) and of undesirable events. [ Time Frame: before the chirurgical intervention and 2, 5, 6, 9 and 13 months after ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Implantation neurostimulators and their auxiliary components :

Stimulateur KINETRA TM modèle 7428, Electrode Resume II modèle 3587A, Extension kit DBS 7482

Detailed Description:

Pilot study included 6 centres (Clermont-Ferrand, Bordeaux, Paris, Créteil, Lyon and Grenoble)

Study progress :

3 months to 1 month before chirurgical intervention : selection of patient that could be included in the protocol.
15 days to 8 days before chirurgical intervention : inclusion visit.
Operating phase : under anaesthesia, implantation of the neurostimulator and its components, and adjustment of stimulation parameters.
1 month after chirurgical intervention : checking that all is fine (detection of undesirable events)
2 months to 5 months after chirurgical intervention: randomization (double blind): the stimulator is put on position On or OFF
5 months after chirurgical intervention : Stimulators of all patients are stopped for one month whatever the group they belong.
6 months to 9 months after chirurgical intervention: Stimulatiors are put on position On or OFF (cross over with the first period).
9 months to 13 months after chirurgical intervention: Stimulators of all patients are started for four months whatever the group they belong.
13 months after chirurgical intervention : study end

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age : >18 years and < 65 years
Evolution time of dystonia > 1 year
Clinical stability of dystonia = 1 year
Secondary dystonia due to a focal lesion (vascular or anoxic) of central grey nuclei
Inefficiency of others treatments (anticholinergic, benzodiazepine, neuroleptique, botulinum toxin, etc.)
Stability of treatment >3 months
Agreement of patients
Affiliation to social security

Exclusion Criteria:

Significant heart vascular disease; significant respiratory, metabolic, renal or hepatic diseases
Significant clinical and biological anomalies
Disease or treatment in favour in bleeding
Sever cognitive disorders
Psychiatric evolutionary pathology
Counter-indication during inclusion examination
Chirurgical counter-indication
Pregnant women ou women who nurse
Person who participate to an other study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505323

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Medtronic

Investigators

Principal Investigator:

Franck DURIF, Pr

unaffiliated

More Information

No publications provided

Responsible Party:	Neurology center ( CHU Clermont-Ferrand )
Study ID Numbers:	2007-A00100-53, PHRC N 2007 DURIF
Study First Received:	July 20, 2007
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00505323 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Cortex stimulation
Focal secondary Dystonia
Effectiveness
Quality of life improvement
Focal dystonias secondary to central grey nuclei lesions

Study placed in the following topic categories:

Dystonic Disorders
Signs and Symptoms
Movement Disorders
Neoplasm Metastasis
Quality of Life

Central Nervous System Diseases
Neurologic Manifestations
Dystonia
Dyskinesias
Focal Dystonia

Additional relevant MeSH terms:

Dystonic Disorders
Signs and Symptoms
Neoplasms
Neoplastic Processes
Pathologic Processes
Movement Disorders

Nervous System Diseases
Neoplasm Metastasis
Central Nervous System Diseases
Neurologic Manifestations
Dystonia
Dyskinesias

ClinicalTrials.gov processed this record on September 11, 2009