CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
transcranial direct current stimulation (tDCS) (active or placebo) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01960400
NCT01960400N/ACompleted

Investigation of the Efficacy of Transcranial Direct Current Stimulation (tDCS) Added to the Graded Motor Imagery (GMI) in the Treatment of Complex Regional Pain Syndrome (CRPS) Type 1

Université de Sherbrooke·interventional·Posted Oct 10, 2013·Updated Feb 6, 2017

In Brief

A clinical study evaluating transcranial direct current stimulation (tDCS) (active or placebo) and Graded motor imagery (GMI) for Reflex Sympathetic Dystrophy. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The efficacy of the current standard non-pharmacological treatments for complex regional pain syndrome (CRPS), a painful syndrome mostly occurring after musculoskeletal trauma, is suboptimal. It thus appears essential to examine new non-pharmacological therapeutic imagery (GMI) - a non-pharmacological approach with the highest level of evidence (level II). As suggested by the most recent clinical guideline 2, a potential solution would be to add an electrotherapeutic procedure - transcranial direct current stimulation (tDCS) - that may prove effective in modulating cortical excitability and reducing the effect of cortical reorganization on pain. Given the positive results previously obtained in patients with neuropathic pain, it is hypothesized that tDCS will prove to be an innovative add-on treatment method for CRPS patients, and help reduce pain and disability.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2013
Enrollment StartApr 1, 2013
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.7 years ago

Interventions

transcranial direct current stimulation (tDCS) (active or placebo)device

TDCS was delivered according to the method described by Fregni et al. (2006) and the safety parameters related to tDCS application were respected (DaSilva et al., 2011). Direct current was delivered using a battery-driven constant current stimulator coupled to saline-soaked (0.9% NaCl) sponge electrodes (5 X 7 cm). Anodal stimulation was delivered over the M1; the anode was placed over C3 or C4 position in the 10/20 system for the EEG electrode position, contralateral to the affected limb, and the cathode over the opposite supraorbital area (i.e. ipsilateral to the affected limb). In the laboratory, a constant current of an intensity of 2 mA was applied for 20 min/day X 5 consecutive days during the first and the second weeks of GMI. To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.

Graded motor imagery (GMI)device

The treatment was performed using a software (Recognise™ online) provided by NOI group (http://www.noigroup.com/recognise). As an alternative to the software (for patients without an internet access), the patient could do the exercises with a Recognise™ Flash Cards set consists of 25 left and 25 right matching images (upper limb or lower limb). Using standardized procedures, inspired from the randomized controlled trial conducted by Moseley (2004, 2006), the participants performed the therapy at home, 10 minutes per session, 3x/day, 6 days/week, using the computer software and a mirror box (Lagueux et al., 2012).