NCT02346396

Brief Summary

The purpose of this study is to confirm the analgesic effect of tDCS in neuropathic chronic pain, to estimate the importance and the duration of this effect, and to improve its efficiency by the use at home. It is established that the repetition of the sessions of cortical stimulation over a week improves their analgesic efficacy. However, this effect does not exceed a few weeks and is much lower than that of the stimulation implanted surgically. Implanted stimulation operates periodically, several times a day, and this "repetition of doses ", akin to the regular taking of a medicine, may explain its longer efficacy for pain relief which, may extend over several years (André-Obadia and al 2014). No study at this date has estimated the long-term effect of non-invasive stimulation when is also periodically repeated on a daily basis, over several weeks.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Feb 2015May 2027

First Submitted

Initial submission to the registry

January 7, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

February 9, 2015

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2027

Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

12.3 years

First QC Date

January 7, 2015

Last Update Submit

December 22, 2023

Conditions

Neuropathic Pain

Keywords

neuropathic painneurostimulationambulatory usetDCS

Outcome Measures

Primary Outcomes (2)

  • Quality of sleep : numerical rating scale (NRS) from 0 (no sleep) to 10 (very good sleep).

    over the week preceding the stimulation (W1), the period of ambulatory stimulation (W2-3-4-5) and the month according to the latter (W6-7-8-9-10)

  • Fatigue : numerical rating scale (NRS) from 0 (exhausted) to 10 (very well)

    over the week preceding the stimulation (W1), the period of ambulatory stimulation (W2-3-4-5) and the month according to the latter (W6-7-8-9-10)

Study Arms (1)

Patients with neuropathic chronic pain

EXPERIMENTAL
Device: tDCS (use at home)

Interventions

tDCS (use at home)DEVICE

During 4 weeks (every week : 20 minutes / day during 5 days)

Patients with neuropathic chronic pain

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients from 18 to 80 years old, men or women, suffering pharmaco-resistant neuropathic chronic pain for more than one year; NVS \> 2 during the week S0) unilateral pharmacoresistant, whose analgesic treatment is stable for at least 1 month.
  • Patients whose pharmacoresistance leads their referent doctor to consider non-pharmacological therapeutic alternatives and begin a presurgical assessment.
  • Patients having an operational Internet connection. The patient or one person of its circle of acquaintances will have to be able to connect on the Internet and to reach by this way the system of relocated stimulation ("The Cloud").
  • Patients having shown pain relief to a single- or whole-week sessions of tDCS are not excluded from potential recruitment for this study.
  • Patients having a social security cover.
  • Patients having given their written consent.

You may not qualify if:

  • History
  • of addiction to drugs,
  • of epilepsy.
  • Présence of an intra-cranial ferromagnetic equipment or of an implanted stimulation device (e.g. stimulating, central grey pacemaker, stimulation of the basal ganglia or of the vagus nerve).
  • Introduction of a new analgesic treatment for less than a month.
  • Lack of a effective contraception for all the duration of the study for the patients old enough to procreate.
  • Patient under legal protective measure.
  • Pregnant women and nursing mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon - Neurological Hospital - University Pain Clinic (CETD)

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Luis Garcia-Larrea, Doctor

CONTACT

4 72 35 78 88larrea@univ-lyon1.fr

Nathalie André-Obadia, Doctor

CONTACT

4 72 35 70 68nathalie.obadia-andre@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Efficacy will be assessed in a single-blind trial, with each patient receiving a series of "placebo" stimulations to check the clinical reality of the effects on pain.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 27, 2015

Study Start

February 9, 2015

Primary Completion (Estimated)

May 9, 2027

Study Completion (Estimated)

May 9, 2027

Last Updated

January 2, 2024

Record last verified: 2023-12

Locations

FR(1)