NCT01500564: ReSTIM

Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol): ReSTIM

Completed NA Last updated 31 January 2018

What this trial tests

NA trial testing anodal tDCS (device) Eldith DC-Stimulator in Stroke in 10 participants. Completed in 31 July 2015.

Timeline

2 January 2012

Primary endpoint
31 July 2015

31 July 2015

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	10
Start date	2 January 2012
Primary completion	31 July 2015
Estimated completion	31 July 2015
Sites	2 locations across France

Drugs / interventions tested

• anodal tDCS (device) Eldith DC-Stimulator
• Sham tDCS

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 18 to 80, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Previous research that utilises single sessions of transcranial direct current stimulation (tDCS) have demonstrated functional improvements. However these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. In these studies, tDCS is typically applied with the goal of adaptively enhancing functional activation of pathologically under-active tissue or suppressing pathologically over-active tissue. Interestingly, a small body of evidence is now emerging to indicate that tDCS can improve learning/memory functions in healthy controls. The goal of this study is to test if the application of tDCS could enhance learning and/or memory for physiotherapy rehabilitation, which may in turn lead to correspondingly greater motor improvement. Patients at a subacute stage (1 to 6 month post stroke) will attend for 10 consecutive daily sessions of tDCS.

This research has important implications; previous studies suggest that such an approach has the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a clinically viable rehabilitative tool. Recovery of motor skills may take many months to acquire and therefore strategies that have the potential to enhance acquisition of skill are of practical and scientific interest.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke.
   Elsner B, Kugler J, Pohl M, Mehrholz J. · · 2016 · cited 89× · PMID 26996760 · DOI 10.1002/14651858.cd009645.pub3
2. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke.
   Elsner B, Kugler J, Pohl M, Mehrholz J. · · 2020 · cited 80× · PMID 33175411 · DOI 10.1002/14651858.cd009645.pub4