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Completed

NCT Number: NCT02817880

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

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.

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Key information

Conditions

Algoneurodystrophy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de la douleur, CHU Grenoble Alpes, Grenoble, Isere, France

Loading trial locations.

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rTMS

Device

tDCS

Device

tsDCS

Device

Primary outcomes

  1. The Visual numeric scale of pain between the three groups

    Time frame: Baseline to 1 month

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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.

  6. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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

Acronym: ALGOSTIM

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Jun 29, 2016
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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