tDCS and Upper Extremity Function in Stroke

NCT06454331 | Completed DMC

• 1 other identifier: REC01900 Tayyab Awan
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Keywords

Stroke; upper limb; tDCS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Stroke Specific Quality of Life

  8 week

Study Arms (2)

Active tDCS

EXPERIMENTAL

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

Sham tDCS Group

SHAM COMPARATOR

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

Device: Sham transcranial direct current stimulation

Interventions

Transcranial direct current stimulation 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.

Active tDCS

Sham transcranial direct current stimulation 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

Sham tDCS Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Mirza Obaid Baig, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: June 24, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: March 2025 to August 2025

Locations

PA (1)