Comparing Transcranial Direct Current Stimulation Montages in Stroke

University of Liege

Status

Unknown

Conditions

Acute Stroke

Treatments

Device: Transcranial Direct Current Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04340973

2017-94

Details and patient eligibility

About

40 acute subjects will be split into 5 groups. Each group will receive one of the following tDCS montages : anodal, bilateral, cathodal, extracephalic or placebo.

Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week.

Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test

Full description

40 acute subjects will be randomized and split into 5 groups.

Each group will receive one of the following tDCS montages :

Anodal : Anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area Bilateral : Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex Cathodal : Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder Placebo : anode montage but current is ramped up over 15 secondes, then ramped down.

Subjects will receive, in addition to conventional rehabilitation (±1.5h/weekday), 2mA for 20 mins of their attributed tDCS, 5 times a week.

All researchers, therapists, data analysis and patients are blinded by a code system implemented in the tDCS machine

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

First Ever Stroke
Motor or sensory deficit
Understands and follows orders
Signed inform consent

Exclusion criteria

One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 5 patient groups, including a placebo group

Anodal

Active Comparator group

Description:

Anodal tDCS: Anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks

Treatment:

Device: Transcranial Direct Current Stimulation

Bilateral

Active Comparator group

Description:

Bilateral : Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex. 2 mA, 20min stimulation, 5 days a week for 4 weeks

Treatment:

Device: Transcranial Direct Current Stimulation

Cathodal

Active Comparator group

Description:

Cathodal : Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks

Treatment:

Device: Transcranial Direct Current Stimulation

Extracephalic

Active Comparator group

Description:

Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder. 2 mA, 20min stimulation, 5 days a week for 4 weeks

Treatment:

Device: Transcranial Direct Current Stimulation

Placebo

Placebo Comparator group

Description:

Placebo : anode montage but current is ramped up over 15 secondes, then ramped down. 2 mA, 20min stimulation, 5 days a week for 4 weeks