Home-use brain stimulation (tDCS) for chronic neuropathic or nociplastic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled, two-center trial comparing active versus sham transcranial direct current stimulation (tDCS) delivered at home. Eligible participants previously experienced at least 30% pain relief from motor-cortex rTMS but lost that benefit within one month and will stop rTMS for at least one month before enrollment. Participants will perform 20-minute tDCS sessions (2 mA) at home five days per week for 12 weeks, with monthly assessments of pain intensity and secondary outcomes such as quality of life, sleep, mood, and global impression of change. Safety is monitored at each follow-up and a blinded interim analysis in the first 40 patients may stop the trial early for futility or safety concerns.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Chronic pain for at least 6 months Pain intensity ≥ 4/10 on 0-10 NRS Pain present every day or nearly every day Neuropathic pain (DN4 score ≥ 4/10) or nociplastic pain (Kosek et al Pain 2021) Patients previously treated with rTMS of the motor cortex in routine in our pain center but with only transient efficacy (ie, efficacy for less than one month, defined as pain intensity improved by at least 30 %) Affilitated to social security

Exclusion Criteria:

Contraindications to tDCS as stated in the manufacturer brochure (ie, implantable device , severe cognitive disorders, epilepsia, skin problems where will placed the electrodes, arterial or venous thrombosis, thrombophlebitis, metallic intracranial implant, cranioth-omy, incracranial aneuvrysm, cerebral tumor, severel sleep disorders such as narcolepsia) Conciomitant treatment which might increase the risk of epilepsia such as high doses opioids (≥ 140 mg morphine equivalent) or high. doses tricyclic antidepressants (≥ 150 mg per day) Pregnancy or lactation Age below 18 or \> 80 years Pending litigation related to pain Pain more severe than neuropathic or nociplastic pain requiring treatment Severe disease such as cancer Severe psychiatric condition (psychosis) Impossible to be followed for up to 3 months Participation in a recent protocol (less than 3 months) Psychoactive drug abuse

Where it's running

• Centre d'Evaluation et de Traitement de la douleur, INSERM U 987
  Boulogne-Billancourt, Hauts de Seine, France Recruiting

Study contacts

• Study coordinator: Nadine ATTAL, MD PhD
• Email: nadine.attal@aphp.fr
• Phone: 0033149095931

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.