Status:
RECRUITING
Efficacy of Home-delivered Transcranial Direct Electrical Stimulation or Chronic Pain
Lead Sponsor:
Hospital Ambroise Paré Paris
Conditions:
Neuropathic Pain
Nociplastic Pain
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This clinical investigation aims to evaluate the efficacy and safety of a home-based device providing electrical stimulation of the brain named transcranial direct current stimulation (tDCS ) , in pat...
Detailed Description
This will be a randomised, double-blind, parallel-group, bi-centric study versus placebo stimulation. Patients undergoing previous treatment with rTMS of the motor cortex in routine in our pain center...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07211256
Start Date
January 9 2025
End Date
February 1 2028
Last Update
October 7 2025
Active Locations (1)
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1
Centre d'Evaluation et de Traitement de la douleur, INSERM U 987
Boulogne-Billancourt, Hauts de Seine, France, 92100