Comparison of the Analgesic Effect Between the Motor Cortex Stimulation and the Trans-spinal Stimulation in the Algoneurodystrophy.

Not Applicable

Completed

• Conditions: Algoneurodystrophy
• Interventions: Device: tsDCS; Device: rTMS; Device: tDCS

• Registration Number: NCT02817880
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The purpose of this study is to compare the analgesic effectiveness of two motor cortex neurostimulations (tDCS and rTMS) and the trans-spinal neurostimulation (tsDCS ) in the algoneurodystrophy.

Detailed Description

* Entry into the study : After informed consent, patients will be randomised into three groups : tDCS, rTMS, tsDCS. The physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (IWRS).

* Baseline : Participants, will record on a book, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 month.

* The beginning of the treatment : after the baseline, sessions of neurostimulation will begin. Sessions of neurostimulation will have a decreasing rhythm. Five sessions per week during the two first weeks, two sessions per week during the third week, one session during the fourth week and then two sessions per month for four months.

* After the end of neurostimulation sessions, patients will be followed for 1month.

Throughout their participation in the study, patients will complete their VNS report book (1month of baseline before the treatment, 3 months during neurostimulation, 1 month after neurostimulation).

Patients will have 5 evaluation examinations:

* The first, one just before the beginning of the neurostimulation,

* The second, 1 month after the beginning of neurostimulation

* The third, 3 months after the beginning of neurostimulation

* And the last one, 1 month after the end of neurostimulation.

Study Timeline

• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-29
• Study Start: 2016-07-25
• Primary Completion: 2021-06-11
• Study Completion: 2022-02-22
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Patient's written consent
• Patient suffering from an algoneurodystrophy for more than a year.
• Diagnosis of algoneurodystrophy confirmed by an osseous scintigraphy
• Stable treatment for at least 1 month
• Patient non-responsive to pharmacological treatments
• VNS > 3 at the time of screening

Exclusion Criteria

• Drug addiction
• History of epilepsy, head trauma, Psychiatric pathology likely to hamper the progress of the study.
• Intracranial ferromagnetic material or an implanted stimulator
• MRI contraindication
• Algoneurodystrophy due to a nervous lesion
• Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tsDCS (transcutaneous spinal Direct Current Stimulation)	tsDCS	tsDCS (transcutaneous spinal Direct Current Stimulation)
rTMS (repetitive transcranial magnetic stimulation)	rTMS	rTMS (repetitive transcranial magnetic stimulation)
tDCS (transcranial direct-current stimulation)	tDCS	tDCS (transcranial direct-current stimulation)

Primary Outcome Measures

Name	Time	Method
The Visual numeric scale of pain between the three groups	Baseline to 1 month

Secondary Outcome Measures

Name	Time	Method
Evolution of the conductance of feet and hands by using Sudoscan	Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)	The body conductance will be used to assess the evolution of the Impact of the neurostimulation on the sympathetic nervous system and on the small fiber neuropathy.
The Clinical Global Impression scale (CGI) between the three groups	Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)
The SF12 quality of life questionnaire between the three groups	Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)
The Neuropathic Pain Symptom Inventory scale (NPSI) between the three groups	Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)
Modifications of the sensori-motor cortical cards by using a MRI	Baseline, and 1 month after the end of the treatment (Day 180)
The Hospital Anxiety and Depression scale (HAD) between the three groups	Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)

Trial Locations

Locations (2)

Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor; 🇫🇷 Créteil, Ile De France, France

Centre de la douleur, CHU Grenoble Alpes; 🇫🇷 Grenoble, Isere, France