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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Comparison of the Analgesic Effect Between the Motor Cortex Stimulation (tDCS and rTMS) and the Trans-spinal Stimulation (tsDCS ) in the Algoneurodystrophy of Members. A R

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 Summary:

  • 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.

Sponsor: University Hospital, Grenoble

Current Primary Outcome: The Visual numeric scale of pain between the three groups [ Time Frame: Baseline to 1 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The Clinical Global Impression scale (CGI) between the three groups [ Time Frame: 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 [ Time Frame: Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180) ]
  • The Hospital Anxiety and Depression scale (HAD) between the three groups [ Time Frame: 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 [ Time Frame: Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180) ]
  • Evolution of the conductance of feet and hands by using Sudoscan [ Time Frame: 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.
  • Modifications of the sensori-motor cortical cards by using a MRI [ Time Frame: Baseline, and 1 month after the end of the treatment (Day 180) ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Grenoble

Dates:
Date Received: June 27, 2016
Date Started: July 2016
Date Completion: October 2019
Last Updated: July 11, 2016
Last Verified: July 2016