tDCS and Upper Extremity Function in Stroke

NCT ID: NCT06454331

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-24
• Study Completion Date: 2025-01-31

Brief Summary

Research on the effects of Anodal transcranial Direct Current Stimulation (tDCS) on hand dexterity and quality of life in stroke patients is limited. While the highlighted article focuses on Parkinson's disease, it underscores anodal tDCS potential to modulate brain activity and promote neural plasticity, suggesting potential relevance to stroke rehabilitation

Detailed Description

tDCS seems like a hopeful way to help stroke patients improve their upper limb function, but there are still some problems and questions that need to be answered. Previous studies have investigated the impact of (tDCS) on upper limb recovery among stroke patients. However, evidence is scarce on the effect of tDCS on hand dexterity and quality of life in stroke patients. Furthermore, these studies have not adequately explored how the severity of stroke influences the efficacy of tDCS on upper limb motor recovery. Additionally, there is a lack of research examining the cumulative effects of tDCS on both upper limb motor recovery and hand dexterity, as well as QoL, particularly concerning stroke severity.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active tDCS

The dosage of anodal tDCS will be 20 minutes with an intensity of 2mA. It's administered before exercise therapy sessions over a period of 8 weeks and 3 times a week

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

The two key landmarks for EEG electrode placement are the nasion and the inion which are used to define the measurement. Measure the distance between the nasion and the inion along the midline of the head. Divide the nasion-inion distance by two to find the midpoint and mark this midpoint on the scalp along the midline. C3 (left hemisphere of the scalp) and C4 (right hemisphere of the scalp), which are placed 20% of the nasion-inion distance from the midline, and M1, which is placed 10% of this distance from the midline, can be determined using these calculations. From the midpoint marked on the scalp, measure to the left and right sides using the calculated 10% and 20% distances. Mark these points as M1 and its mirror position. Clean the scalp at the marked M1 and its mirror position locations to remove any oils or debris.

Sham tDCS Group

sham tDCS, task-oriented training (i.e. placing cones on another cone, inserting needles into a box

Group Type: SHAM_COMPARATOR

Sham transcranial direct current stimulation

Intervention Type: DEVICE

it can apply in sitting or supine lying position but it's important to ensure their comfort and safety while facilitating optimal electrode placement and contact with the scalp. Duration of 20 minutes, with Intensity of 0.5mA, and density of 0.02 mA/cm² for 8 weeks on alternative days

Interventions

Transcranial direct current stimulation

The two key landmarks for EEG electrode placement are the nasion and the inion which are used to define the measurement. Measure the distance between the nasion and the inion along the midline of the head. Divide the nasion-inion distance by two to find the midpoint and mark this midpoint on the scalp along the midline. C3 (left hemisphere of the scalp) and C4 (right hemisphere of the scalp), which are placed 20% of the nasion-inion distance from the midline, and M1, which is placed 10% of this distance from the midline, can be determined using these calculations. From the midpoint marked on the scalp, measure to the left and right sides using the calculated 10% and 20% distances. Mark these points as M1 and its mirror position. Clean the scalp at the marked M1 and its mirror position locations to remove any oils or debris.

Intervention Type: DEVICE

Sham transcranial direct current stimulation

it can apply in sitting or supine lying position but it's important to ensure their comfort and safety while facilitating optimal electrode placement and contact with the scalp. Duration of 20 minutes, with Intensity of 0.5mA, and density of 0.02 mA/cm² for 8 weeks on alternative days

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Stroke for more than 6 months.
• Age 40-80 years
• Both gender
• 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

• Any patient with Upper limb amputation on the effected side, contracture, burn injury that leads to joint limitation and functional limitation.
• Known cases of Multiple Sclerosis and Parkinson and any Musculoskeletal disorder and Cardiopulmonary disorder.
• Any patient with Metallic implants
• Individuals with a history of seizures or epilepsy
• Individuals with Skin allergies on the scalp

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mirza Obaid Baig, MSPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC01900 Tayyab Awan

Identifier Type: -

Identifier Source: org_study_id