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

NCT04644718 | Unknown DMC

• 1 other identifier: IRB-2020-03-112
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

aphasia; arabic; Transcranial Direct Current Stimulation; Rehabilitation; Speech Language Therapy; Speech Language Pathology; Language

Outcome Measures

Primary Outcomes (1)

• GACAT (Naming noun, Naming action, Word fluency, and Sentence production) are assessing change.

  Outcome measures are assessing the changes in GACAT following domains (Naming noun, Naming action, Word fluency, and Sentence production) across all time points. Thus we are using the same outcome measures across all time points. As we are evaluating the maintenance of the functional recovery throughout time points.

  At baseline, immediately post-treatment, 6-month follow-up, and 12-month follow up.

Secondary Outcomes (1)

• GACAT (Cognitive function, Emotional well-being, and Quality of life) assessing change.

  At baseline, immediately post-treatment, 6-month follow-up, and 12-month follow up

Study Arms (2)

Anodal-tDCS with speech therapy

EXPERIMENTAL

The participant will complete six consecutive weeks of SLT accompanied with real tDCS. Each session starts with 20 minutes of tDCS followed by the SLT program.

Device: Transcranial direct current stimulation (tDCS)

sham tDCS with speech therapy

SHAM COMPARATOR

The participant will complete six consecutive weeks of SLT accompanied with sham tDCS. Each session starts with 20 minutes of tDCS followed by the SLT program.

Device: Transcranial direct current stimulation (tDCS)

Interventions

Transcranial direct current stimulation (tDCS) DEVICE

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.

Anodal-tDCS with speech therapy; sham tDCS with speech therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18-70 years old) native Arabic speakers with first-ever symptoms of aphasia due to cortical or subcortical stroke in the left hemisphere in individuals who have had these symptoms for six months and more post-onset.
• The included participants with aphasia should demonstrate 50% or greater on the auditory verbal comprehension section of the GACAT with a cut score of 54 of total comprehension of spoken language in GACAT.
• Moderate to severe individuals with aphasia will be included in the study. These included individuals will include individuals with non-fluent aphasia only for sake of homogeneous study population. The nature (fluent versus no fluent) and severity (mild-moderate-Severe) of aphasia will be determined primarily by GACAT, and secondary by clinical history and patients' interview.
• The GACAT T-scores in naming total are used to determine aphasia severity as follows: mild aphasia ≥ 72, moderate aphasia 71-66, and severe aphasia ≤ 65.
• Recruitment of participants will include both sexes.

You may not qualify if:

• The individuals who found to have any of the contraindications for tDCS.
• These contraindications include but not restricted to (cardiac pacemaker, history of seizures, implanted metal inside the head) (Pulvermüller and Fadiga, 2010).
• Furthermore; individuals with confirmed severe neurological diseases such as: epilepsy, brain tumor, and subdural hematoma are excluded from the study.

Sponsors & Collaborators

• Imam Abdulrahman Al Faisal Hospital: lead

MeSH Terms

Conditions

Aphasia; Communication Disorders; Language

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Communication; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: For blinding purposes, a masked set of randomization procedures designed to keep both participants and experimenters unaware of the administered intervention (real or sham; mode of stimulation) in addition to group allocation concealment (Alonzo et al., 2016; Fonteneau et al., 2019). The randomization sequence will be encrypted and stored on a secure server to confirm blinding process. Independent Endpoint committee blinded to group assignment and time of assessment will evaluate the collected data to further enhance blinding integrity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof/Consultant

Model Details: Patients will be randomly assigned to one of the two groups in a ratio of 1:1 with the use of permuted-block randomization design. The first intervention group will receive real tDCS with SLT, while the second group (control group) will receive sham tDCS with same SLT protocol.

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: November 25, 2020
• Study Start: February 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 30, 2020

Record last verified: 2020-11