tDCS and Lower Limb Performance in Stroke

Riphah International University

Status: Not yet enrolling

Conditions: Stroke

Treatments: Device: tDCS; Device: Sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT06463795

REC01898 Saira Muzaffar Shah

Details and patient eligibility

About

Lower limb rehabilitation is especially important, as the simple act of regaining the ability to walk has subsequent effects on the ability to engage in activities of daily living .So, this study will contribute in describing the management of lower limb motor recovery along with the therapeutic intervention (MRP) with tDCS (anodal stimulation). This study aims to address some of the drawbacks observed in previous studies like allocation concealment, small sample size due to drop outs, short term effects of tDCS and experimental designs as well.

Full description

Transcranial Direct Current Stimulation (tDCS) appears to be an intriguing adjuvant for stroke neurorehabilitation, though there are many other methods available. Depending on the polarity used, tDCS alters cortical excitability when electrodes applied over the motor cortex area (M1) to be stimulated, and the cathode above the contralateral eye (Orbital area), tDCS (thus termed anodal) increases cortical excitability. It is easy to use, safe and has minimal side effects like a sensation of itching, post-stimulation headache and sometimes mild nausea may experience. Numerous research indicates that cortical activity rises in conjunction with gait. According to a number of studies, corticospinal neuron activity either parallels or possibly even partially regulates the activity of spinal motor neurons during walking. There exist various techniques for implementing transcranial direct current stimulation in conjunction with multiple supplementary therapies.

Enrollment: 80 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stroke for more than 6 months.
• National Institutes of Health Stroke Scale (NIHSS) for severity level (Mild (1-4), Moderate (5-15), Moderate to Severe (16-20), Severe (21-42)

Exclusion criteria

• Epilepsy
• Scalp injury/ skin lesion e.g. psoriasis or eczema etc.
• Patient with lower limb amputation or any MSK/neurological disorder that limit the LE function
• Implanted medical devices including intracranial electrodes, surgical clips, shrapnel or a pacemaker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

tDCS Group

Experimental group

Description:

Electrode placement: Anodal electrode placed over primary motor cortex area (M1) while the cathode placed over contralateral orbit. Duration of 20 minutes with intensity of 2mA, ramping up and down at 8 seconds. the density of 0.07 C/cm2 for 3 days/week for 8 weeks

Treatment:

Device: tDCS

Sham Group

Sham Comparator group

Description:

Electrode placement: Anodal electrode placed over primary motor cortex area (M1) while the cathode placed over contralateral orbit. Duration of 20 minutes with intensity of 0.5mA, ramping up and down at 150 and 30 seconds respectively. There will be brief stimulation period of 3-5% active session duration the density of 0.07 C/cm2 for 3 days/week for 8 weeks

Treatment:

Device: Sham tDCS