tDCS and Upper Extremity Function in Stroke

Effects of Transcranial Direct Cranial Stimulation on Upper Limb Function and Quality of Life in Stroke Patients

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Transcranial direct current stimulation; Device: Sham transcranial direct current stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan
      • Pakistan Railway General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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.
Sham Comparator: Sham tDCS Group; sham tDCS, task-oriented training (i.e. placing cones on another cone, inserting needles into a box	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FMA-Upper Extremity	The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is a clinical tool for evaluating motor recovery in stroke and neurological conditions affecting the upper limbs and with a sensitivity of 77%, a specificity of 89%. It assesses motor function through tasks like reaching and grasping, scored on a 3-point scale. Higher scores indicate better function, with a maximum score of 66. Clinicians use it to track progress, plan treatment, and assess outcomes in rehabilitation settings	8 week
Action Research Arm Test	The Action Research Arm Test (ARAT) is a clinical assessment tool used to evaluate upper limb function and recovery in individuals who have experienced a stroke or other neurological conditions affecting arm movement. The ARAT consists of a series of 19 items/tasks that assess different aspects of upper limb function, including reaching, grasping, gripping, and manipulating objects of various sizes and shapes. The tasks are scored based on the individual's ability to complete them successfully and the quality of movement exhibited during the task. Scores range from 0 to 3. (0=Unable to perform, 1= Partially performs the task, 2= Completes the task with some difficulty and 3= Completes the task without difficulty)	8 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Specific Quality of Life	The of Stroke Specific Quality of Life (SS-QOL) questionnaire is a tool used to assess the quality of life in individuals who have experienced a stroke. The SS-QOL reveals a sensitivity of 70.0% and a specificity of 75.8%. It measures various domains including physical function, mobility, social participation, emotional well-being, and cognition. The SS-QOL helps clinicians and researchers understand the impact of stroke on a person's overall quality of life and modify interventions accordingly	8 week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Mirza Obaid Baig, MSPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: tDCS; Stroke; upper limb
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: REC01900 Tayyab Awan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: March 2025 to August 2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No