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NCT Number: NCT07361692

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.

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Key information

Conditions

Complex Regional Pain Syndrome (CRPS) Anxiety Disorders Autonomic Nervous System Diseases Complex Regional Pain Syndromes Mental Disorders Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

transcranial direct current stimulation

Other

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

Other

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.

Primary outcomes

  1. Analog Visual Scale

    Time frame: one month post treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Valentin Billard

CONTACT

[email protected]

02 51 16 16 16

Sponsors and collaborators

Lead sponsor

Polyclinique de l'Europe

Other

Registry information

Official study title

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

Acronym: ALGOSTIM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 23, 2026
Registry last updated
Jun 18, 2026

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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