Neuropathic PainHomestim-DCNCT07211256
Efficacy of Home-delivered Transcranial Direct Electrical Stimulation or Chronic Pain
A study testing tDCS of the motor cortex in people with Neuropathic Pain and Nociplastic Pain, run by Hospital Ambroise Paré Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain, Nociplastic Pain
- What is being tested?
- tDCS of the motor cortex
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre d'Evaluation et de Traitement de la douleur, INSERM U 987
Boulogne-Billancourt, Hauts de Seine, 92100
Nadine Pr ATTAL, MD PhD, 0033149095931, nadine.attal@aphp.fr
Didier Bouhassira, MD, PhD, 0033149094556, didier.bouhassira@aphp.fr
About this study
Official title: 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
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.
Read the 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 and with at least 30 % pain relief with rTMS (after 10 sessions) but only transient pain relief (less than one month) will stop their treatment for at least one month. They will then be randomised to receive one of the 2 treatments under study (active tDCS of the motor cortex, placebo tDCS of the motor cortex, TENS eco plus). The protocol will involve a 20-minute tDCS session (2 mA) at home, 5 days a week for 12 weeks. The treatment will continue for 12 weeks and the final evaluation will take place at 12 weeks.
TENS ECO PLUS is a portable transcranial direct current stimulation (tDCS) system (tDCS kit) supplied by the Monath Electronic laboratory, designed for use at home; this system will first be tested in hospital during a test session with explanations to the patient on how to use it. The stimulation intensity is blocked above a certain threshold by the system to avoid any risk of epileptic seizure. Sham or placebo stimulation uses the same medical device without active stimulation.
Given the exploratory nature of the trial and in order to reduce study participant's exposure to a potentially useless treatment, blinded interim analysis will be conducted dring the course of the trial in the first 40 enrolled patients and the study will be stopped early if this analysis suggests large differences between the two treatment groups or conversely shows obvious futility.
- Conditions
- Neuropathic Pain, Nociplastic Pain
- Being tested
- tDCS of the motor cortex
- Keywords
- randomized, neuropathic pain, nociplastic pain, placebo controlled, tDCS, home-delivered
- Medical subject headings
- Neuralgia, Nociplastic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS of the motor cortexDevice
Home-delivered tDCS device
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | Active tDCS of the motor cortex Receives: Device: tDCS of the motor cortex |
| Sham tDCS | Sham comparator | Sham tDCS of the motor cortex Receives: Device: tDCS of the motor cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reported pain intensity in a diary
Weekly average of the last 7 numerical pain scores (from 0 no pain to 10 maximal pain imaginable) recorded every day by the patient at the end of the treatment as compared to baseline values
Measured: Baseline and 12 weeks
Secondary outcomes (21)
Effects on self reported pain intensity over the course of the study
Weekly averaged pain intensity on numerical pain scales (0-10, with 0 no pain and 10 maximal pain imaginable) self reported on pain diary over the course of the study
Measured: over the course of the study from baseline to week 12
EQ-5D-5L (EuroQol)
Quality of life on EQ-5D-5L scale including 5 levels of perceived problems each rated on 0-3 categorical scales
Measured: Baseline, then week 1 (± 3 days), week 4, week 8 and week 12
Brief Pain Inventory
Average pain on numerical pain scales (from O no pain to 10 maximal pain) on the Brief Pain Inventory (BPI)
Measured: Baseline, then week 1 (± 3 days), week 4, week 8 and week 12
Neuropathic Pain Symptom Inventory (NPSI)
Self reported neuropathic pain questionnaire to assess 5 neuropathic dimensions rated on the same numerical rating scales (from 0 no symptom to 10 maximal symptom). This questionnaire will be proposed only for neuropathic patients.
Measured: Baseline, then week 1, week 4, week 8 and week 12 after the treatment
Fibromyalgia Impact Questionnaire (FIQ)
Self reported questionnaire assessing the impact of fibromyalgia on everyday life. This questionnaire will only be proposed to patients with fibromyalgia.
Measured: Baseline, then week 1 (± 3 days), week 4, week 8 and week 12
Hospital anxiety and depression scale (HADS)
Symptoms of anxiety rated on 21 on the HADS with 0 indicating no anxiety and 21 indicating the maximal level of anxiety
Measured: Baseline, then week 1 (± 3 days), week 4, week 8 and week 12
Medical outcomes study sleep scale (MOS sleep)
Sleep impairement on the MOS sleep allowing to calculate two indexes (sleep problem index 6 and 9)
Measured: Baseline, then week 1 (± 3 days), week 4, week 8 and week 12
McGill pain questionnaire short form (SF-MPQ)
SF-MPQ (Melzack et al 1986) allowing to evaluate the sensory and affective dimension of pain; the sensory dimension of pain is rated on 30 with 30 indicating more severe sensory dimension of pain
Measured: Baseline, then week 1 (± 3 days), week 4, week 8 and week 12
Pain Catastrophizing Scale (PCS)
Pain catastrophizing on the PCS (Sullivan et al), scored from 0 to 52 (with 52 indicating worse catastrophizing)
Measured: Baseline then 1 week ± 3 days then 4 weeks, 8 weeks and 12 weeks
Patient global impression of change (PGIC)
PGIC as assessed on a 7 category scale from much improved to much deteriorated
Measured: Baseline then 4 weeks, 8 weeks and 12 weeks
Treatment-emergent adverse effects of home delivered tDCS
Treatment emergent adverse effects will be assessed at each follow up visit by the investigators. Patients will also report any adverse effect occurring immediately after each session of tDCS or between sessions on a self diary.
Measured: Every day over the course of the study and at each follow up visit, at days 3 (initial follow up safety visit) then days 10, week 4, week 8 and week 12
Categorical pain scale
Categorical pain scale (from no pain to very severe pain)
Measured: Baseline then 10 days (± 3 days), 4, 8 and 12 weeks
Blinding assessment
A blinding assessment as used in our prior studies will be proposed to every patient including 2 questions : what treatment they think they had received (active or placebo) ; the main reason for their choice (efficacy, side effects, both, other reasons)
Measured: 12 weeks
Satisfaction with the treatment
Satisfaction with the treatment will be assessed on a 0 to 10 numerical scale (0 = not satisfied ; 10 : extremely satisfied)
Measured: 12 weeks
Interference score of the Brief Pain Inventory
Interference score rated from 0 to 70 from the Brief Pain Inventory
Measured: Baseline then 1 week, 4 weeks, 8 weeks and 12 weeks after the treatment
Pain as its least from the Brief Pain Inventory
Pain intensity as its least over the past 24 hours rated on a numerical rating scale from 0 to 10
Measured: Baseline then 1 week, 4 weeks, 8 weeks and 12 weeks after the treatment
Pain as its worst from the Brief Pain Inventory
Pain intensity as its worst over the past 24 hours rated on a 0-10 numerical rating scale
Measured: Baseline then 1 week, 4 weeks, 8 weeks and 12 weeks
Clinician global impression of change (CGIC)
7 category Clinician based global impression of change from severe deterioration to significant improvement
Measured: Baseline and at 12 weeks
EQ5D -5L Euroqol Visual analog scale
Visual analog scale rated from 0 to 100 to measure health status with 0 being the worse health status and 100 being the best possible health status
Measured: Baseline, week. 1, weeks 4, weeks 8 and weeks 12 after the treatment
Symptoms of depression on the Hospital Anxiety and Depression Scale (HADS)
Symptoms of depression rated on 21 on the HADS with 0 indicating no anxiety and 21 indicating the maximal level of depression
Measured: Baseline then one week, 4 weeks, 8 weeks and 12 weeks
Short Form McGill Pain Questionnaire SF-MPQ
SF-MPQ allowing to evaluate the affective dimension of pain; the affective dimension of pain is rated from 0 to 12 with 12 indicating more severe sensory dimension of pain
Measured: Baselinen one week, 4 weeks, 8 weeks and 12 weeks after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start9 Jan 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine ATTAL, Hospital Ambroise Paré Paris
- Investigators
- Nadine ATTAL, MD PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211256
- Sponsor's protocol ID
- 2023-A02797-38
- Acronym
- Homestim-DC
- Status last verified
- Sep 2025
- First submitted
- 11 Nov 2024
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Problem of confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07211256
- Acronym / sponsor ID
- Homestim-DC / 2023-A02797-38
- Conditions
- Neuropathic Pain, Nociplastic Pain
- Keywords
- randomized, neuropathic pain, nociplastic pain, placebo controlled, tDCS, home-delivered
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 and with at least 30 % pain relief with rTMS (after 10 sessions) but only transient pain relief (less than one month) will stop their treatment for at least one month. They will then be randomised to receive one of the 2 treatments under study (active tDCS of the motor cortex, placebo tDCS of the motor cortex, TENS eco plus). The protocol will involve a 20-minute tDCS session (2 mA) at home, 5 days a week for 12 weeks. The treatment will continue for 12 weeks and the final evaluation will take place at 12 weeks.
TENS ECO PLUS is a portable transcranial direct current stimulation (tDCS) system (tDCS kit) supplied by the Monath Electronic laboratory, designed for use at home; this system will first be tested in hospital during a test session with explanations to the patient on how to use it. The stimulation intensity is blocked above a certain threshold by the system to avoid any risk of epileptic seizure. Sham or placebo stimulation uses the same medical device without active stimulation.
Given the exploratory nature of the trial and in order to reduce study participant's exposure to a potentially useless treatment, blinded interim analysis will be conducted dring the course of the trial in the first 40 enrolled patients and the study will be stopped early if this analysis suggests large differences between the two treatment groups or conversely shows obvious futility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: tDCS of the motor cortexActive tDCS of the motor cortex |
| Sham tDCS | Sham comparator | Device: tDCS of the motor cortexSham tDCS of the motor cortex |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS of the motor cortexHome-delivered tDCS device | Device | Active tDCS, Sham tDCS |
Primary outcome
Self reported pain intensity in a diary
Time frame: Baseline and 12 weeks
Weekly average of the last 7 numerical pain scores (from 0 no pain to 10 maximal pain imaginable) recorded every day by the patient at the end of the treatment as compared to baseline values
21 secondary outcomes
Effects on self reported pain intensity over the course of the study
Time frame: over the course of the study from baseline to week 12
EQ-5D-5L (EuroQol)
Time frame: Baseline, then week 1 (± 3 days), week 4, week 8 and week 12
Brief Pain Inventory
Time frame: Baseline, then week 1 (± 3 days), week 4, week 8 and week 12
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Baseline, then week 1, week 4, week 8 and week 12 after the treatment
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Baseline, then week 1 (± 3 days), week 4, week 8 and week 12
Hospital anxiety and depression scale (HADS)
Time frame: Baseline, then week 1 (± 3 days), week 4, week 8 and week 12
Medical outcomes study sleep scale (MOS sleep)
Time frame: Baseline, then week 1 (± 3 days), week 4, week 8 and week 12
McGill pain questionnaire short form (SF-MPQ)
Time frame: Baseline, then week 1 (± 3 days), week 4, week 8 and week 12
Pain Catastrophizing Scale (PCS)
Time frame: Baseline then 1 week ± 3 days then 4 weeks, 8 weeks and 12 weeks
Patient global impression of change (PGIC)
Time frame: Baseline then 4 weeks, 8 weeks and 12 weeks
Treatment-emergent adverse effects of home delivered tDCS
Time frame: Every day over the course of the study and at each follow up visit, at days 3 (initial follow up safety visit) then days 10, week 4, week 8 and week 12
Categorical pain scale
Time frame: Baseline then 10 days (± 3 days), 4, 8 and 12 weeks
Blinding assessment
Time frame: 12 weeks
Satisfaction with the treatment
Time frame: 12 weeks
Interference score of the Brief Pain Inventory
Time frame: Baseline then 1 week, 4 weeks, 8 weeks and 12 weeks after the treatment
Pain as its least from the Brief Pain Inventory
Time frame: Baseline then 1 week, 4 weeks, 8 weeks and 12 weeks after the treatment
Pain as its worst from the Brief Pain Inventory
Time frame: Baseline then 1 week, 4 weeks, 8 weeks and 12 weeks
Clinician global impression of change (CGIC)
Time frame: Baseline and at 12 weeks
EQ5D -5L Euroqol Visual analog scale
Time frame: Baseline, week. 1, weeks 4, weeks 8 and weeks 12 after the treatment
Symptoms of depression on the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline then one week, 4 weeks, 8 weeks and 12 weeks
Short Form McGill Pain Questionnaire SF-MPQ
Time frame: Baselinen one week, 4 weeks, 8 weeks and 12 weeks after the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No. Problem of confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadine ATTAL, MD PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS of the motor cortex in people with Neuropathic Pain and Nociplastic Pain, run by Hospital Ambroise Paré Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadine ATTAL, MD PhD (0033149095931, nadine.attal@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self reported pain intensity in a diary (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.