Efficacy of Home-delivered Transcranial Direct Electrical Stimulation or Chronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHospital Ambroise Paré Paris
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
tDCS of the motor cortex
DeviceHome-delivered tDCS device
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Active tDCSActive comparator 1 intervention
Group B: Sham tDCSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline and 12 weeksSecondary outcomes
1
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
Time frame
over the course of the study from baseline to week 122
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
Time frame
Baseline, then week 1 (± 3 days), week 4, week 8 and week 123
Brief Pain Inventory
Average pain on numerical pain scales (from O no pain to 10 maximal pain) on the Brief Pain Inventory (BPI)
Time frame
Baseline, then week 1 (± 3 days), week 4, week 8 and week 124
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.
Time frame
Baseline, then week 1, week 4, week 8 and week 12 after the treatmentOther outcomes
1
Predictors of the response to tDCS
Clinical predictors of the response to tDCS will be assessed based on multivariate analyses taking into account the patients profiles at baseline
Time frame
Baseline2
Easyness of use
Patients will be questioned at each time point over the course of the study about the easyness of use of the home based device, whether they experienced difficulty and which were they. These will be assessed by open questions only.
Time frame
Days 3-5, then week 1, then weeks 4, 8 and 12 after the treatment3
Predictor of the response to placebo
A specific questionnaire will be used to assess the risk of placebo response
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov