Effectiveness of Transcranial Direct Current Stimulation (tDCS) in the Management of Complex Regional Pain Syndrome (ALGOSTIM)

June 17, 2026 updated by: Polyclinique de l'Europe

Study of the Effectiveness of Transcranial Direct Current Stimulation (tDCS) in the Management of Complex Regional Pain Syndrome

Transcranial direct current stimulation (tDCS) is a non-invasive therapy increasingly used in facilities treating patients with chronic pain. This complementary therapy has the advantage of being non-pharmacological, with transient and mild side effects, an excellent safety profile, and good efficacy in the contexts where it has been the subject of dedicated research: neuropathic pain, fibromyalgia, and visceral pain. Few studies have focused on the application of tDCS in the context of complex regional pain syndrome (CRPS), which is a common condition.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This protocol aims to compare a group receiving a tDCS protocol with a sham control group. The hypothesis of this study is that tDCS is effective in treating CRPS in terms of reducing pain and the functional and emotional consequences of pain.

The primary objective of the study is to evaluate the effectiveness of tDCS on pain in patients with CRPS (complex regional pain syndrome), measured by the numerical pain scale (EN), after one month of treatment and one month after the end of treatment, compared to the sham arm.

The secondary objectives are:

  • To assess anxiety and depression symptoms (HAD)
  • To assess the functional impact of pain (Concise Pain Questionnaire - QCD)
  • To assess central sensitization (Central Sensitization Inventory - CSI)
  • To identify adverse effects related to tDCS

Study Type

Interventional

Enrollment (Estimated)

32

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 Contact

Study Locations

  • France
      • Saint-Nazaire, France, 44600

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Major
  • Clinically active or active complex regional pain syndrome (CRPS) with positive Budapest criteria
  • Scintigraphy showing signs consistent with CRPS
  • Being affiliated with or a beneficiary of a social security scheme

Exclusion Criteria:

  • Algodystrophy no longer meeting the Budapest criteria
  • Relative contraindication to tDCS: psychosis (including treated psychosis), uncontrolled epilepsy, large scalp scar, intracerebral/intracranial metallic body
  • Pregnant or breastfeeding women
  • Minors
  • Persons under legal protection (guardianship, conservatorship, and protective supervision)
  • Persons deprived of their liberty by judicial or administrative order
  • Unwilling individuals who cannot give their consent or cannot return for scheduled visits according to the protocol

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: Patient group receiving tDCS stimulation
Progressive increase in stimulation intensity up to 2 mA, then continuation at a plateau for a total of 20 minutes, then a decrease in stimulation intensity for 30 seconds at the end of the session before an automatic stop.
Other: transcranial direct current stimulation
progressive increase in stimulation intensity up to 2 mA, then continuation at a plateau for a total of 20 minutes, then a decrease in stimulation intensity for 30 seconds at the end of the session before an automatic stop.
Placebo Comparator: Patient group receiving tDCS placebo stimulation
Control group : The stimulation intensity is gradually increased up to 2 mA for 1 minute, then decreased to zero stimulation. A further increase in stimulation is programmed 10 minutes after the start of stimulation.
Other: Placebo
The stimulation intensity is gradually increased up to 2 mA for 1 minute, then decreased to zero stimulation. A further increase in stimulation is programmed 10 minutes after the start of stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analog Visual Scale
Time Frame: one month post treatment
one month post treatment

Collaborators and Investigators

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

Sponsor

Polyclinique de l'Europe

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)

April 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-20-ESN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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