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

May 17, 2022 updated by: University Hospital, Grenoble

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 Randomised Clinical Trial. tDCS : Transcranial Direct-current Stimulation rTMS : Repetitive Transcranial Magnetic Stimulation tsDCS : Transcutaneous Spinal Direct Current Stimulation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile De France
      • Créteil, Ile De France, France, 94010
        • Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor
    • Isere
      • Grenoble, Isere, France, 38043
        • Centre de la douleur, CHU Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS (repetitive transcranial magnetic stimulation)
Device: rTMS
Experimental: tDCS (transcranial direct-current stimulation)
Device: tDCS
Experimental: tsDCS (transcutaneous spinal Direct Current Stimulation)
Device: tsDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Visual numeric scale of pain between the three groups
Time Frame: Baseline to 1 month
Baseline to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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)
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.
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
Time Frame: Baseline, and 1 month after the end of the treatment (Day 180)
Baseline, and 1 month after the end of the treatment (Day 180)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2016

Primary Completion (Actual)

June 11, 2021

Study Completion (Actual)

February 22, 2022

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC15.158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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