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

NCT00505323 | Completed Phase 1

• 2 other identifiers: 2007-A00100-53PHRC N 2007 DURIF
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Focal Dystonia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 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.

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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Chirurgical counter-indication
• Pregnant women ou women who nurse
• Person who participate to an other study

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Medtronic: collaborator

MeSH Terms

Conditions

Dystonic Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Franck DURIF, Pr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: July 23, 2007
• Study Start: September 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 8, 2014

Record last verified: 2014-07