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The Effect of Transcranial Direct Current Stimulation and Speech Language Therapy to Improve Language Functioning in Arabic Speakers With Aphasia Post-Stroke

NCT04644718 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-11-30

No results posted yet for this study

Summary

The current planned study is a prospective randomized double-blind, sham-controlled, two parallel-groups, polycentric, phase-I superiority type of trial. Right-handed native Arabic-speaking patients with chronic aphasia post-stroke will be recruited from multiple in and outpatient rehabilitation centers in Saudi Arabia. All participants with aphasia that exceeds at least six months post onset with deficits in naming skills due to ischemic lesion or haemorrhage in the left cerebral hemisphere will be included. All participants will complete three consecutive phases: (i) baseline assessment, (ii) interventions (Speech and Language Therapy (SLT) with real tDCS or sham tDCS, and (iii) outcome testing (GACAT test).

The primary hypothesis predicts improvement in naming ability (object naming and action verb naming) and word fluency by combining SLT with anodal-tDCS (intervention group) compared to SLT combined with sham-tDCS (control group). Primary endpoint will be a 6-month follow-up, at which will be expected to show the effects of improvement in the language impairments. The secondary hypothesis predicts that anodal-tDCS will yield beneficial results in secondary outcomes measures compared to sham-tDCS. Secondary endpoint will be immediately post-treatment and a 12-month follow-up, and it will examine the consistency effect of long-term outcomes.

Conditions

  • Aphasia

Interventions

DEVICE

Transcranial direct current stimulation (tDCS)

tDCS will be administered using a battery driven stimulator along with intensive SLT. The anode electrode (5-7cm2) will be placed over the left M1 while the cathode will be positioned over the controlateral supraorbital area in both groups ((Lindenberg et al., 2013; Meinzer et al., 2016; Stahl et al., 2019), (based on the 10-20 EEG system) (Darkow et al., 2017). Stimulation will be provided via an electrode using a Soterix device (Soterix Medical Inc., New York, NY). During sham tDCS (control group), the current will be ramped up and remained for 30 s at (2 mA) before ramping down, which does not affect neural functions, but assures effective blinding of participants due to the initial tingling sensation on the scalp (Gandiga et al., 2006). Both groups will receive a total of 30 consecutive stimulation sessions over six weeks.

Sponsors & Collaborators

  • Imam Abdulrahman Al Faisal Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-04-01
Completion
2022-09-01

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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 NCT04644718 on ClinicalTrials.gov