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CompletedNCT06454331Updated Mar 24, 2025

tDCS and Upper Extremity Function in Stroke

An interventional study of Transcranial direct current stimulation and Sham transcranial direct current stimulation in Stroke, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-24.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • Stroke
  • upper limb
  • tDCS
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 70 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceTranscranial 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.

  • DeviceSham 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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 8 week

  2. 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)

    Time frame: 8 week

Secondary outcomes

  1. 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

    Time frame: 8 week

07

Study locations

1 site
  • Pakistan Railway General Hospital
    Rawalpindi, Punjab, Pakistan
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06454331
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jun 12, 2024
Start date
Jun 24, 2024
Primary completion
Dec 31, 2024
Completion
Jan 31, 2025
Last update
Mar 24, 2025

Study contacts

Mirza Obaid Baig, MSPT
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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