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

NCT06110169 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-11-02

No results posted yet for this study

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

Interventions

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.

DEVICE

Sham Transcranial Direct Current Stimulation (tDCS)

Participants will receive 20 minutes of sham anodal tDCS

Sponsors & Collaborators

  • Karthick Balasubramanian

    lead OTHER_GOV

Principal Investigators

  • Mohammed Mansour Alshehri, PhD · Assistant professor, Department of Physical Therapy, Jazan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-02-29
Completion
2024-04-30

Countries

  • Saudi Arabia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06110169 on ClinicalTrials.gov