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NCT Number: NCT00505323

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

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.

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Key information

Conditions

Focal Dystonia Central Nervous System Diseases Dystonic Disorders Movement Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of neurostimulators and their auxiliary components

Device

Implantation neurostimulators and their auxiliary components :

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: CORDYS

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jul 23, 2007
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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