tDCS for Neurological Disability Among Subacute Stroke Survivors to Improve Multiple Domains in Quality of Life

October 31, 2023 updated by: Karthick Balasubramanian

Transcranial Direct Current Stimulation (tDCS) for Neurological Disability Among Subacute Stroke Survivors to Improve Multiple Domains in Quality of Life (QoL): Randomized Controlled Trial Protocol

Background: tDCS is an emerging noninvasive brain stimulation that triggers neuroplastic changes in the brain. To enhance motor and executive function, tDCS modifies neuronal activity. Targeted effects of tDCS for physical and cognitive function might help in improving domains related to QoL among stroke survivors. Therefore, the primary goal of the current proposal is to fill the gaps in the literature by studying the effectiveness of patient-tailored tDCS on lifestyle parameters, and physical, behavior, and cognitive functions among stroke survivors, and understanding the mediated factors of domains related to QoL improvements.

Type of study: Multiple Randomized Controlled trials (RCTs) Methods: Multiple RCTs will be conducted for subacute stroke survivors (>7 days to 3 months post stroke) aged 40-75 years with National Institutes of Health stroke scale score of >10 and Mini-Mental State Examination Score between18-23 on admission. Anticipated 64 Participants will take part in a prospective, randomized, participant- and assessor-blinded, sham-controlled trial after voluntary consent. The participants will be randomly assigned at a ratio of 1:1 to receive either: 16 patient-tailored sessions of anodal tDCS or sham tDCS in addition to conventional rehabilitation. Battery driven tDCS will be applied at 2 mA intensity to the dorsolateral prefrontal cortex and primary motor cortex for 20 minutes. The primary endpoints of study will be differences in 36-Item Short Form Survey (SF-36) scores post intervention at 4 weeks. The secondary outcomes will include Stroke Specific Quality of Life Scale, Montreal cognitive assessment, Beck Anxiety Inventory, Fugl-Meyer Assessment and Barthel Index.

Results: SPSS software version 22 will be used to analyze the normal distribution of data and based on data normality, within group and between group actual differences will be calculated for all outcome measures to examine the main effects of the intervention. The level of significance will be set at 0.05

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Ischemic stroke (IS) is a major health concern worldwide. There are approximately 29 stroke cases per 100,000 of population residing in Saudi Arabia annually. Stroke is the second leading cause of mortality and a major contributor to adult disability in Saudi Arabia. Two-thirds of stroke patients continue to have motor impairments that have an impact on daily activities and quality of life. Survivors may continue to require specialised therapy assistance for months or even years following a stroke. Lack of inpatient and community rehabilitation, long-term care, and community support services has a substantial influence on patients with non-acute phase of stroke, thus urgent and acute care is not the only part of care that needs to improve. To offer better results for patients with stroke, rehabilitation programmes, primary care teams, social care professionals, and larger community services must all contribute their time and effort. These requirements seek to delve into the broader and more immediate facets of stroke treatment. The recovery of motor function following IS depends on the initiation of rehabilitative training at an early stage.

Inter-hemispheric balance is disrupted after stroke, interfering with the recovery process. Motor functions depend on the modulation of inter-hemispheric inhibition between cortical areas via transcallosal projections and descending projections. Unilateral hemispheric damage reduces activity in the affected hemisphere while activity in the unaffected hemisphere increases, becoming more dominant. Hence recovery may relate to rebalancing of inter-hemispheric inhibition. The safe, portable and noninvasive brain stimulation method known as tDCS can modify the excitability of certain brain regions by changing the polarity of the neuronal membrane potentials using sponge electrodes. Transcranial brain stimulation (TBS), when used in conjunction with neurorehabilitation in the early subacute phase after IS (within the first 4 weeks after stroke onset), may promote quicker and better recovery by enhancing underlying neuroplastic processes, which may be more susceptible at this time. tDCS alters neuronal activity and induces neuroplastic changes in the brain to improve motor and executive performance. Multiple sessions of tDCS may be utilized to enhance rehabilitative outcomes and lessen symptom load across a variety of Stroke. The targeted effects of tDCS on physical and functional aspects may contribute to an improvement in QoL-related areas. In Saudi Arabia, there is a significant gap between evidence-based stroke medication and care. Stroke has been deemed a high priority illness by the Ministry of Health that requires better management Therefore, the main objective of the current proposal is to close the gaps in the literature by researching the effects of tailored tDCS on lifestyle variables, as well as on physical, behavioral, and cognitive functions in stroke survivors, and by figuring out the factors that mediate the effects of various domains on QoL.

Study Type

Interventional

Enrollment (Estimated)

64

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

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:

  • Males and Females between the age group of 40 to 75 years
  • Acute first-ever unilateral infarction which is confirmed by MRI.
  • Subacute stroke (Ischemic type) (>7 days to 3 months post stroke)
  • Modified Ashworth scale < 2 in both upper and lower extremity
  • Mini-Mental State Examination Score between18-23 on admission
  • National Institutes of Health stroke scale score of >10 on admission
  • Clear consciousness able to sign the informed consent

Exclusion Criteria:

  • Sensorimotor cortical infarcts
  • Epilepsy
  • Diagnosed as hemorrhagic stroke
  • Any neurological diseases other than stroke
  • Any musculoskeletal injury affecting motor functions
  • Any neuropsychiatric diseases
  • Any medically unstable condition due to Cardiovascular or respiratory illness.
  • Severe medical diseases or other systemic illness like malignancy, end stage kidney, heart or liver failure
  • Pregnancy, presence of metallic implants, pacemaker
  • Hypersensitive patients, Non-Cooperative or unwilling Individuals

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (anodal tDCS)
Participants will receive 20 minutes of anodal tDCS
Device: Anodal Transcranial Direct Current Stimulation (Anodal tDCS)
Battery driven tDCS will be applied at 2 mA intensity to the dorsolateral prefrontal cortex and primary motor cortex for 20 minutes.
Sham Comparator: Group B (sham tDCS)
Participants will receive 20 minutes of sham anodal tDCS
Device: Sham Transcranial Direct Current Stimulation (tDCS)
Participants will receive 20 minutes of sham anodal tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36 will be used to measure overall health status
Time Frame: At the beginning and at the end of intervention at 4 weeks intervention
The SF-36 is an indicator of overall health status consisting of 10 Items. SF-36 is well validated and the reliability exceeds 0.80 in most studies. The score range is between 0-100, lower score indicate more disability. The sections of SF-36 include Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning & Mental health.
At the beginning and at the end of intervention at 4 weeks intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment will be used to evaluate the physical performance of an individual following stroke.
Time Frame: At the beginning and at the end of intervention at 4 weeks intervention
The Fugl-Meyer Assessment is a reliable, multi-item, performance-based impairment index. It is categorized into 4 different domains, that is, motor function, joint range of motion, sensory function, balance and joint pain. Each domain contains multiple items scored on a three-point ordinal scale. The motor domain items evaluate movement coordination and reflex activity of the upper extremity and lower extremity joints. The upper extremity motor score ranges from 0 to 66, the lower extremity motor score range varies from 0 to 34 (total motor score of 100 points). Light touch and pain constitute sensory domains with the total score ranging between 0 and 24 (0 -12 for upper and lower extremity each), passive range of motion and joint pain scores range from 0 to 44 (0 -24 for upper extremity & 0-20 for lower extremity
At the beginning and at the end of intervention at 4 weeks intervention
Montreal cognitive assessment will be sued to assess the cognitive domains
Time Frame: At the beginning and at the end of intervention at 4 weeks intervention
The Montreal cognitive assessment is a brief screening tool for cognitive domains providing a quick assessment of the global cognitive state of an individual in a short period of time. It includes the assessment of short-term memory, executive functions, visuospatial abilities, language, attention, concentration, working memory, and temporal and spatial orientation. Memory testing is done by a delayed recall of 5 nouns learned in 2 trials
At the beginning and at the end of intervention at 4 weeks intervention
Stroke-specific quality of life will be used to evaluate the Quality of life of individuals following stroke
Time Frame: At the beginning and at the end of intervention at 4 weeks intervention
Stroke-specific quality of life is a standardized, reliable (reliability coefficient 0.92), validated scale that specifically measures the quality of life of individuals that have had a stroke. The scale consists of 12 items grouped into physical and psychological subscales and 49 items, a 1 to 5 point range is used for scoring each item. The total range of scores vary from 49 to 245. The lowest score indicates poor quality of life he change score of an individual patient has to reach 5.9, 4.0, and 5.3 on the 3 subscales to indicate a true change. The mean change scores of a group of patients with stroke on these subscales should reach the lower bound of CID ranges of 1.5 (6.3% scale width), 1.2 (6.0% scale width), and 1.2 (6.0% scale width) to be regarded as clinically important change
At the beginning and at the end of intervention at 4 weeks intervention
Beck Anxiety Inventory used to assess post stroke depression
Time Frame: At the beginning and at the end of intervention at 4 weeks intervention
The sensitivity of the self-rated scales varied between 80% and 90%, while the specificity is estimated about 60%. The instrument is widely used to assess post stroke depression
At the beginning and at the end of intervention at 4 weeks intervention
Barthel Index used to measure disability/activities of daily living
Time Frame: At the beginning and at the end of intervention at 4 weeks intervention
Barthel index has excellent validity and reliability to measure disability/activities of daily living (ADL) and is widely used as outcome for stroke rehabilitation
At the beginning and at the end of intervention at 4 weeks intervention

Collaborators and Investigators

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

Sponsor

Karthick Balasubramanian

Investigators

  • Principal Investigator: Mohammed Mansour Alshehri, PhD, Assistant professor, Department of Physical Therapy, Jazan 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 (Estimated)

November 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tDCS for stroke survivors

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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