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

NCT06110169 | Unknown

• 1 other identifier: tDCS for stroke survivors
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke; Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• SF-36 will be used to measure overall health status

  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 Outcomes (5)

• Fugl-Meyer Assessment will be used to evaluate the physical performance of an individual following stroke.

  At the beginning and at the end of intervention at 4 weeks intervention

• Montreal cognitive assessment will be sued to assess the cognitive domains

  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

  At the beginning and at the end of intervention at 4 weeks intervention

• Beck Anxiety Inventory 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

  At the beginning and at the end of intervention at 4 weeks intervention

Study Arms (2)

Group A (anodal tDCS)

EXPERIMENTAL

Participants will receive 20 minutes of anodal tDCS

Device: Anodal Transcranial Direct Current Stimulation (Anodal tDCS)

Group B (sham tDCS)

SHAM COMPARATOR

Participants will receive 20 minutes of sham anodal tDCS

Device: Sham Transcranial Direct Current Stimulation (tDCS)

Interventions

Anodal Transcranial Direct Current Stimulation (Anodal tDCS) DEVICE

Battery driven tDCS will be applied at 2 mA intensity to the dorsolateral prefrontal cortex and primary motor cortex for 20 minutes.

Group A (anodal tDCS)

Sham Transcranial Direct Current Stimulation (tDCS) DEVICE

Participants will receive 20 minutes of sham anodal tDCS

Group B (sham tDCS)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karthick Balasubramanian: lead

Study Sites (1)

University Hospital, Jazan University

Jizan, 45142, Saudi Arabia

Location

Related Publications (5)

• Alqahtani BA, Alenazi AM, Hoover JC, Alshehri MM, Alghamdi MS, Osailan AM, Khunti K. Incidence of stroke among Saudi population: a systematic review and meta-analysis. Neurol Sci. 2020 Nov;41(11):3099-3104. doi: 10.1007/s10072-020-04520-4. Epub 2020 Jun 20.

  PMID: 32564272 BACKGROUND

• Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.

  PMID: 24505342 BACKGROUND

• Winters C, van Wegen EE, Daffertshofer A, Kwakkel G. Generalizability of the Proportional Recovery Model for the Upper Extremity After an Ischemic Stroke. Neurorehabil Neural Repair. 2015 Aug;29(7):614-22. doi: 10.1177/1545968314562115. Epub 2014 Dec 11.

  PMID: 25505223 BACKGROUND

• Cassidy JM, Cramer SC. Spontaneous and Therapeutic-Induced Mechanisms of Functional Recovery After Stroke. Transl Stroke Res. 2017 Feb;8(1):33-46. doi: 10.1007/s12975-016-0467-5. Epub 2016 Apr 25.

  PMID: 27109642 BACKGROUND

• Divya M, Narkeesh A. Therapeutic Effect of Multi-Channel Transcranial Direct Current Stimulation (M-tDCS) on Recovery of Cognitive Domains, Motor Functions of Paretic Hand and Gait in Subacute Stroke Survivors-A Randomized Controlled Trial Protocol. Neurosci Insights. 2022 Mar 30;17:26331055221087741. doi: 10.1177/26331055221087741. eCollection 2022.

  PMID: 35392020 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic 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

• Mohammed Mansour Alshehri, PhD

  Assistant professor, Department of Physical Therapy, Jazan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed Mansour Alshehri, PhD

CONTACT

0096503946253; moAlshehri@jazanu.edu.sa

Karthick Balasubramanian

CONTACT

00966535721053; bkarthick@jazanu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, Department of Physical Therapy, College of Applied Medical Sciences, Jazan University

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: November 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-10

Locations

SA (1)