A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke

Zhejiang University

Status: Unknown

Conditions: Cognitive Dysfunction

Treatments: Device: multi-channel tDCS; Device: single-channel tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT04133714

2019-313

Details and patient eligibility

About

This clinical RCT study intends to combined different forms of multi-channel tDCS with the routine cognitive training process to treat patients with post-stroke cognitive dysfunction.

The therapeutic effects among single-channel tDCS group, multi-channel tDCS and pseudo-multichannel tDCS group will be compared. Brain magnetic resonance mechanism research will also be included to reveal the possible mechanism of multi-channel tDCS technology for PSCI brain network.

Thus, the efficacy and mechanism of multi-channel tDCS in post-stroke cognitive function rehabilitation will be researched both in the clinical and basic levels.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-60 year-old
• diagnosed cerebral apoplexy, meeting the diagnostic criteria of ICD-10
• cognitive function, perceptual function decline after stroke
• first onset and duration of 3-12 months
• right-handed
• MMSE ≤25
• MoCA ≤25
• sign informed consent voluntarily and comply with the study plan

Exclusion criteria

• NIHSS ≥21 points
• MoCA ≤18, or DRS-2 ≤ 124, or CES-D ≥ 16
• taking drugs that affect central nervous activity, such as nerve antagonists
• specific contraindication, such as electrode patch allergy, local skin injury or - - - - inflammation, and hyperalgesia in stimulated areas
• patients use implantable electronic devices (such as cardiac pacemakers) or have - metal implants such as stents that affect MRI examination
• patients with a previous history of epilepsy, mental illness or skull injury
• patients with dementia or obvious cognitive dysfunction before stroke
• patients with aphasia or dysarthria and cannot complete the scale evaluation
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

multi-channel tDCS

Experimental group

Description:

In the multi-channel tDCS stimulation group, a 1:4 (anode: cathode) approach was applied, with the central anode placed in the left dorsolateral prefrontal cortex (dlPFC) (reference 10-20 standard lead EEG), and the remaining cathode distributed around the central electrode. The rising time and falling time of current are 30 seconds respectively. Stimulate 30 minutes daily for 10 days (Monday to Friday, once a day, weekend off).

Treatment:

Device: multi-channel tDCS

single-channel tDCS

Experimental group

Description:

The anode electrode of the single-channel tDCS stimulation group was placed in the left dlPFC, and the cathode electrode was placed in the right orbital forehead. The rising time and falling time of current are 30 seconds respectively. Stimulate 30 minutes daily for 10 days (Monday to Friday, once a day, weekend off).

Treatment:

Device: single-channel tDCS

sham stimulation

Sham Comparator group

Description:

The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation.

Treatment:

Device: multi-channel tDCS

Device: single-channel tDCS