tDCS and Spasticity in Stroke Patients

March 19, 2025 updated by: Riphah International University

Effects Of Transcranial Direct Current Stimulation On Spasticity In Stroke Patients

Multiple research has worked on tDCS and its impact on stroke. But none have studied the effects of tDCS on stroke in relation to the different stages of stroke like mild, moderate, moderate to severe and severe stroke as per national institute of health (NIH) scale.

Additionally, this study will be conducted to address the few drawbacks in previous studies such as short follow up period by employing evidence based standardized protocols. It can potentially instigate the efficacy of tDCS on spasticity, motor recovery and Quality of life in relation to the different severity levels of stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Multiple noninvasive brain stimulation is also introduced over the few years regarding their impact on spasticity, tDCS being the most common due to its effects on spasticity. There are multiple structural and functional changes in motor cortex post stroke, tDCS causes improvement in motor control by reorganizing the motor cortex. Anodal and cathodal tDCS are based on the current direction with cathodal decreasing excitability of the cortex area and anodal increasing it. Anodal tDCS is more effective in reducing spasticity as compared to cathodal. The change in cortical excitation alters the reflex arc i.e. altering the neurons and reducing their excitability which causes a decrease in tone and facilitates neuroplasticity.

Spasticity is often found along with weakness in stroke and is one of the reasons for impaired motor function, increased resistance to stretch and is due to increased excitability and abnormal regulation of spindle and reflex arc. With chronicity and reduced motor control spasticity also increases by 97 %. Spasticity and paresis lead to impaired motor control. Spasticity will not change recovery in function in early stages but is going to affect motor recovery in all stages. Spasticity disrupts motor function and the daily tasks which creates different levels of dependence in the patients hence effecting the QOL. Spasticity is found in almost 40% of individuals suffering from stroke. It affects joints and extremities in a way that impedes function and ADLs. Painful, restricted joints resulting from prolonged spasticity badly impacts the QOL leading to high burden on caregivers

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 466000
      • Rawalpindi, Punjab, Pakistan
        • Recruiting
        • Pakistan Railway Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stroke for more than 6 months.
  • Both genders.
  • Spasticity score ≥1 at modified ashworth scale.
  • 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:

  • Have any metallic implant including intracranial electrode, pacemaker, surgical clip.
  • Any symptoms effecting understanding of instructions.
  • Any neurological disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional
Other: Conventional
ROM exercises for upper and lower extremities, Stretching of agonists, Strengthening of antagonists, Core stability exercises, Static and dynamic balance activities, Gait training, Functional training
Experimental: tDCS
Other: tDCS
Stimulation in each session will be applied for 20 min by two 5 × 4 cm (20 cm2) saline-soaked sponge electrodes at an intensity of 1.5 mA (0.075 mA/cm2). A gradual ramp up and down of stimulation for 10 s at the beginning and the end of stimulation
Other: Conventional
ROM exercises for upper and lower extremities, Stretching of agonists, Strengthening of antagonists, Core stability exercises, Static and dynamic balance activities, Gait training, Functional training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale
Time Frame: 8 week
MAS is a tool to measure hypertonia. It scores the resistance on a 5 point ordinal scale with an increase value indicating hypertonia. Intrarater reliability of MAS was found to be good to excellent for upper (k= 0.71-0.94) and lower extremities(k= 0.55-0.97) while interrater reliability was poor to moderate for upper (k= 0.25-0.66)and lower extremities (k= 0.41-0.54)
8 week
Fugl Meyr Assessment
Time Frame: 8 week
FMA is used for the assessment of physical performance and sensorimotor function of neurological patients. It uses a 3-point ordinal scale to score individuals' ability to perform a certain task. Total score is 226. It has excellent inter and intrarater reliability. (ICC 0.95)
8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SS-QoL
Time Frame: 8 week
It is used for estimating the quality of life of stroke patients. It contains 49 questions related to different personal and social aspects. Scoring is done on a ordinal scale of 1-5 with an increase score indicating independence. It is a valid and reliable tool to use in stroke population (Cronbach's alpha 0.903)
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Actual)

September 19, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC02039 Aqsa Liaqat

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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