Home-use brain stimulation (tDCS) for chronic neuropathic or nociplastic 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
NA · Hospital Ambroise Paré Paris · NCT07211256
This trial will test whether using a home tDCS device for 12 weeks can reduce pain in people with chronic neuropathic or nociplastic pain who had only short-term relief from rTMS.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Ambroise Paré Paris (other) |
| Locations | 1 site (Boulogne-Billancourt, Hauts de Seine) |
| Trial ID | NCT07211256 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with chronic (≥6 months) neuropathic or nociplastic pain who had at least 30% but short-lived (<1 month) pain relief after motor-cortex rTMS and who can use a home device are ideal candidates.
Not a fit: Patients with contraindications to tDCS (implantable devices, epilepsy, severe cognitive or skin conditions), on high-risk medications, or those unlikely to tolerate the device are unlikely to benefit.
Why it matters
Potential benefit: If successful, home tDCS could provide a convenient way to extend or restore pain relief without repeated hospital rTMS visits.
How similar studies have performed: Prior randomized trials and meta-analyses show modest and mixed benefits of tDCS for chronic pain, but home-delivered tDCS, particularly in patients selected after rTMS, remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boulogne-Billancourt, Hauts de Seine
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuropathic Pain, Nociplastic Pain, randomized, neuropathic pain, nociplastic pain, placebo controlled, tDCS, home-delivered