Cortical Stimulation by Direct Current for the Treatment of Chronic Pain : Pilot-study of a Stimulation Device at Home

Not Applicable

Recruiting

• Conditions: Neuropathic Pain
• Interventions: Device: tDCS (use at home)

• Registration Number: NCT02346396
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-27
• Study Start: 2015-02-09
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2024-01-02
• Primary Completion: 2027-05-09
• Study Completion: 2027-05-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with neuropathic chronic pain	tDCS (use at home)	-

Primary Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Hospices Civils de Lyon - Neurological Hospital - University Pain Clinic (CETD); 🇫🇷 Bron, France