NCT03888209

Transcranial Direct Current Stimulation (tDCS) Improves Functional Outcomes in Acute Stroke Patients

Transcranial Direct Current Stimulation ASsociated With Physical-therapy In Acute Stroke Patients - the tDCS ASAP - a Randomized, Triple Blind, Sham-controlled Study ?

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Liege · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Acute stroke patient will undergo one month (20 sessions) of physical therapy and anodal tDCS. Patients will undergo functional outcomes measured at 48h post onset, 7,14,21,28 days, 3 and 6 months and one year post onset.

Detailed description

Recruitment : Patients with acute stroke (24-48h after stroke) who have upper and / or lower sensorimotor deficits • Treatment : After being selected according to the inclusion and exclusion criteria of this study, patients will be randomized and placed in one of two groups: placebo (P) or transcranial anodic stimulation (A). Once placed in one of two groups, patients will all receive intensive physiotherapy for functional improvement in order to increase motor, postural and motor control. This physiotherapy will be established 5 times a week (Monday to Friday). In addition to physiotherapy, the patient will have electrodes placed on his head, attached via a system of straps, to deliver either a continuous current (A) or no current (P) and at a rate of 5 times per week for 4 weeks. Neither the physiotherapist nor the patient will know what treatment he will have received. • Evaluations and measurements: Patients will be required to perform functional tests of the upper limb (Wolf Motor Function Test (WMFT)), filmed and timed, a test of spasticity (Tardieu) as well as to answer certain questionnaires concerning their perception of the evolution of the disease and their disability (Stroke Impact Scale, Barthel Index), their emotional state (HADS), if they have experienced side effects, sensitivity test with monofilaments or Semmes and Weinstein test, the Fugl Meyer, the timed up and go, the test of 10m, the four step square test, the berg balance scale, the postural assessment scale and the trunk impairment scale. These evaluations will take place at Day 0 (corresponding to the first day after the 48h of strict bedtime), Day 7, 15, 30, 90, 6 months and 1 year. They will be done in two stages, on two successive days, so as not to exhaust the patient.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
DEVICE	tDCS	20 minutes of anodal tDCS (C3/FP2 or C4/FP1 depending on side of lesion) 2mA or sham

Timeline

• Start date: 2019-03-31
• Primary completion: 2020-06-30
• Completion: 2020-08-31
• First posted: 2019-03-25
• Last updated: 2019-04-03

Locations

1 site across 1 country: Belgium