Efficacy of Cortex Stimulation in Neuropathic Pain

Rebel Neuropathic Pains Clinical Trial

Official title:

Evaluation of the Effectiveness of Stimulation Cortex Sensorimotor for the Treatment of Rebel Neuropathic Pains

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00224666
• Other study ID #: P000901
• Secondary ID: AOM98134
• Status: Terminated
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: January 9, 2007
• Start date: March 2001
• Est. completion date: November 2005

Study information

• Verified date: January 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The pains chronic neurogeneses remain difficult to treat whatever are their origin and their localization. The pharmacological therapeutic arsenal answers only partially the symptomatology often very invalidating which these chronic painful patients present. Electric stimulations of the central nervous system currently validated, in particular of the posterior cords of marrow made a significant improvement in a certain number of indications. Nevertheless, considerable patients are not relieved significantly, in particular those presenting of the pains neurogeneses of central origin (syndromes thalamic for example). It is within this framework that recently the stimulation of the sensorimotor cortex developed.

Principal objective: evaluation of the technique of stimulation under cortical on neuropathic pains .

Description:

The pains chronic neurogeneses remain difficult to treat whatever are their origin and their localization. The pharmacological therapeutic arsenal answers only partially the symptomatology often very invalidating which these chronic painful patients present. Electric stimulations of the central nervous system currently validated, in particular of the posterior cords of marrow made a significant improvement in a certain number of indications. Nevertheless, considerable patients are not relieved significantly, in particular those presenting of the pains neurogeneses of central origin (syndromes thalamic for example). It is within this framework that recently the stimulation of the sensorimotor cortex developed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Neurofibromatosis,

• Rebel chronic neuropathic pain with duration > 1 year and AVS > = 4

Exclusion Criteria:

• Cancer

• Epilepsy

• Cognitive deterioration

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Rebel Neuropathic Pains

Intervention

Device:
• Cortex stimulation

Locations

Country	Name	City	State
France	Hopital Henri Mondor	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Drouot X, Oshino S, Jarraya B, Besret L, Kishima H, Remy P, Dauguet J, Lefaucheur JP, Dollé F, Condé F, Bottlaender M, Peschanski M, Kéravel Y, Hantraye P, Palfi S. Functional recovery in a primate model of Parkinson's disease following motor cortex stimulation. Neuron. 2004 Dec 2;44(5):769-78. — View Citation

Lefaucheur JP, Drouot X, Menard-Lefaucheur I, Zerah F, Bendib B, Cesaro P, Keravel Y, Nguyen JP. Neurogenic pain relief by repetitive transcranial magnetic cortical stimulation depends on the origin and the site of pain. J Neurol Neurosurg Psychiatry. 2004 Apr;75(4):612-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of 50% of EVS at 3 weeks
Secondary	Efficacy of 50% of EVS at 6 months and 12 months