Efficacy of Home-delivered Transcranial Direct Electrical Stimulation or Chronic Pain
Efficacy of Home-delivered Transcranial Direct Current Stimulation (tDCS) of the Motor Cortex in Patients With Chronic Pain Transiently Relieved by Motor Cortex rTMS : a Pragmatic Randomized Double Blind Sham Controlled Trial
Hospital Ambroise Paré Paris
70 participants
Jan 9, 2025
INTERVENTIONAL
Conditions
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 patients with chronic pain who have been transiently relieved by repetitive transcranial magnetic stimulation delivered at hospital (less than one month benefit). The general objective is to show that these patients may best benefit from home based tDCS while rTMS performed in hospital has only limited and transient efficacy. Each participant will be randomized into one of two arms to receive during 3 months either active tDCS or sham tDCS. Neither the investigator nor the patient will be aware of the treatment. The efficacy will be assessed on pain intensity (primary outcome at 3 months) and several secondary outcomes (qualify of life, pain symptoms , global impression of change, pain relief, sleep, anxiety, depression) every month for up to 3 months. Safety will be assessed at each follow up visit for up to 3 months. The participants will be asked to self stimulate themselves with the device 5 days per week for about 20 minutes.
Eligibility
Inclusion Criteria1
- 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 Criteria1
- 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
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Interventions
Home-delivered tDCS device
Locations(1)
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NCT07211256