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

Primary Purpose

Algoneurodystrophy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
rTMS
tDCS
tsDCS
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Algoneurodystrophy focused on measuring rTMS, tDCS, tsDCS, pain, algoneurodystrophy , neurostimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor
  • Centre de la douleur, CHU Grenoble Alpes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

rTMS (repetitive transcranial magnetic stimulation)

tDCS (transcranial direct-current stimulation)

tsDCS (transcutaneous spinal Direct Current Stimulation)

Arm Description

rTMS (repetitive transcranial magnetic stimulation)

tDCS (transcranial direct-current stimulation)

tsDCS (transcutaneous spinal Direct Current Stimulation)

Outcomes

Primary Outcome Measures

The Visual numeric scale of pain between the three groups

Secondary Outcome Measures

The Clinical Global Impression scale (CGI) between the three groups
The SF12 quality of life questionnaire between the three groups
The Hospital Anxiety and Depression scale (HAD) between the three groups
The Neuropathic Pain Symptom Inventory scale (NPSI) between the three groups
Evolution of the conductance of feet and hands by using Sudoscan
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

Full Information

First Posted
June 27, 2016
Last Updated
May 17, 2022
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02817880
Brief Title
Comparison of the Analgesic Effect Between the Motor Cortex Stimulation and the Trans-spinal Stimulation in the Algoneurodystrophy.
Acronym
ALGOSTIM
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 Randomised Clinical Trial. tDCS : Transcranial Direct-current Stimulation rTMS : Repetitive Transcranial Magnetic Stimulation tsDCS : Transcutaneous Spinal Direct Current Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 25, 2016 (Actual)
Primary Completion Date
June 11, 2021 (Actual)
Study Completion Date
February 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Algoneurodystrophy
Keywords
rTMS, tDCS, tsDCS, pain, algoneurodystrophy , neurostimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS (repetitive transcranial magnetic stimulation)
Arm Type
Experimental
Arm Description
rTMS (repetitive transcranial magnetic stimulation)
Arm Title
tDCS (transcranial direct-current stimulation)
Arm Type
Experimental
Arm Description
tDCS (transcranial direct-current stimulation)
Arm Title
tsDCS (transcutaneous spinal Direct Current Stimulation)
Arm Type
Experimental
Arm Description
tsDCS (transcutaneous spinal Direct Current Stimulation)
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Type
Device
Intervention Name(s)
tsDCS
Primary Outcome Measure Information:
Title
The Visual numeric scale of pain between the three groups
Time Frame
Baseline to 1 month
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)
Title
Evolution of the conductance of feet and hands by using Sudoscan
Description
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.
Time Frame
Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor
City
Créteil
State/Province
Ile De France
ZIP/Postal Code
94010
Country
France
Facility Name
Centre de la douleur, CHU Grenoble Alpes
City
Grenoble
State/Province
Isere
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
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Comparison of the Analgesic Effect Between the Motor Cortex Stimulation and the Trans-spinal Stimulation in the Algoneurodystrophy.

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