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

Focal Dystonia Clinical Trial

— CORDYS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00505323
• Other study ID #: 2007-A00100-53
• Secondary ID: PHRC N 2007 DURI
• Status: Completed
• Phase: Phase 1
• First received: July 20, 2007
• Last updated: July 4, 2014
• Start date: September 2007
• Est. completion date: June 2011

Study information

• Verified date: July 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Focal Dystonia

Intervention

Device:
• Implantation of neurostimulators and their auxiliary components
Implantation neurostimulators and their auxiliary components : Stimulateur KINETRA TM modèle 7428, Electrode Resume II modèle 3587A, Extension kit DBS 7482

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Medtronic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of dystonia by using the validated "Burke Fahn and Marsden (1985)" dystonia rating scale		before the chirurgical intervention and 2, 5, 6, 9 and 13 months after	Yes
Secondary	Evaluation of spasticity (Ashworth), of akinesy (Tapping score), of pain (EVA test), of quality of life (SF 36 scale) and of undesirable events.		before the chirurgical intervention and 2, 5, 6, 9 and 13 months after	Yes