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Clinical Trials/NCT02346396
NCT02346396
Recruiting
Not Applicable

Non-invasive Analgesic Stimulation of the Motor Cortex at Home

Hospices Civils de Lyon1 site in 1 country40 target enrollmentFebruary 9, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuropathic Pain
Sponsor
Hospices Civils de Lyon
Enrollment
40
Locations
1
Primary Endpoint
Fatigue : numerical rating scale (NRS) from 0 (exhausted) to 10 (very well)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 9, 2015
End Date
May 9, 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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).

Time Frame: 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 Sites (1)

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