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

NCT02817880 | Completed

• 1 other identifier: 38RC15.158
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Algoneurodystrophy

Keywords

rTMS, tDCS, tsDCS, pain, algoneurodystrophy , neurostimulation

Outcome Measures

Primary Outcomes (1)

• The Visual numeric scale of pain between the three groups

  Baseline to 1 month

Secondary Outcomes (6)

• 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 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)

• 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)

• 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)

Study Arms (3)

rTMS (repetitive transcranial magnetic stimulation)

EXPERIMENTAL

rTMS (repetitive transcranial magnetic stimulation)

Device: rTMS

tDCS (transcranial direct-current stimulation)

EXPERIMENTAL

tDCS (transcranial direct-current stimulation)

Device: tDCS

tsDCS (transcutaneous spinal Direct Current Stimulation)

EXPERIMENTAL

tsDCS (transcutaneous spinal Direct Current Stimulation)

Device: tsDCS

Interventions

rTMS DEVICE

rTMS (repetitive transcranial magnetic stimulation)

tDCS DEVICE

tDCS (transcranial direct-current stimulation)

tsDCS DEVICE

tsDCS (transcutaneous spinal Direct Current Stimulation)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (2)

Centre de la douleur, CHU Grenoble Alpes

Grenoble, Isere, 38043, France

Location

Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor

Créteil, Île-de-France Region, 94010, France

Location

Related Publications (44)

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  BACKGROUND

• Delon-Martin C, Lefaucheur JP, Hodaj E, Sorel M, Dumolard A, Payen JF, Hodaj H. Neural Correlates of Pain-Autonomic Coupling in Patients With Complex Regional Pain Syndrome Treated by Repetitive Transcranial Magnetic Stimulation of the Motor Cortex. Neuromodulation. 2024 Jan;27(1):188-199. doi: 10.1016/j.neurom.2023.05.005. Epub 2023 Aug 16.

  PMID: 37589642 RESULT

• Lefaucheur JP, Delon-Martin C, Hodaj H. Functional coupling between chronic pain and the autonomic nervous system revealed by neuromodulation techniques. Comment on 'Effect of neuromodulation for chronic pain on the autonomic nervous system: a systematic review' (BJA Open 2024; 11: 100305). BJA Open. 2025 Mar 29;14:100393. doi: 10.1016/j.bjao.2025.100393. eCollection 2025 Jun. No abstract available.

  PMID: 40223918 RESULT

• Hodaj H, Payen JF, Hodaj E, Sorel M, Dumolard A, Vercueil L, Delon-Martin C, Lefaucheur JP. Long-term analgesic effect of trans-spinal direct current stimulation compared to non-invasive motor cortex stimulation in complex regional pain syndrome. Brain Commun. 2023 Jul 1;5(4):fcad191. doi: 10.1093/braincomms/fcad191. eCollection 2023.

  PMID: 37545548 RESULT

MeSH Terms

Conditions

Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: July 25, 2016
• Primary Completion: June 11, 2021
• Study Completion: February 22, 2022
• Last Updated: December 17, 2025

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)