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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Completed

CT.gov ID

NCT00505323

Collaborator

Medtronic (Industry)

Enrollment

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Focal Dystonia	Device: Implantation of neurostimulators and their auxiliary components	Phase 1

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

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Outcome Measures

Primary Outcome Measures

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]

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. [before the chirurgical intervention and 2, 5, 6, 9 and 13 months after]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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