The Use of Transcranial Direct Current Stimulation in the Rehabilitation of Post-Stroke Dysphagia During the Subacute Phase in Hospitalized Patients: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- ACompare the effectiveness of the intervention
Study Overview
Brief Summary
The purpose of this clinical trial is to determine whether the use of tDCS in dysphagia rehabilitation during the subacute phase of stroke assists in the recovery process while patients are still hospitalized. Patients aged 60 to 80 years who have suffered a stroke and are in the subacute phase of the disease, admitted to the hospital, will be recruited to receive tDCS application contralateral to the lesion for 10 sessions, combined with conventional speech-language therapy for swallowing rehabilitation. The primary question it aims to answer is whether the use of tDCS combined with swallowing rehabilitation accelerates recovery compared to conventional speech-language therapy alone.
Detailed Description
This clinical trial will be conducted at a regional hospital located in Belém, Pará (Northern Brazil), from July 2026 to March 2027. The sample will consist of 66 participants who have suffered an ischemic or hemorrhagic stroke and present with oropharyngeal dysphagia as a sequela, classified as mild/moderate, moderate, or moderate/severe according to the Dysphagia Risk Assessment Protocol (PARD) (Padovani, 2007).
Patients must be hospitalized and in the subacute phase of the disease (defined as from the 8th day post-onset onwards, confirmed by imaging exams), admitted to the adult ICU, neurological ward, or internal medicine ward. Additionally, they must be hemodynamically stable with a Glasgow Coma Scale score above 13, as specified in the inclusion criteria.
The protocol will involve the application of anodal tDCS contralateral to the neurological lesion, using an intensity of 1.4 mA, with the cathodal electrode positioned in the contralateral supraorbital region. The control group will receive sham stimulation, and both groups will receive conventional rehabilitation for dysphagia treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inpatients at Hospital Regional Dr. Abelardo Santos. Aged 60 to 80 years. Diagnosis of neurogenic oropharyngeal dysphagia ranging from mild-to-moderate, moderate, to moderate-to-severe (Padovani et al., 2007).
- •Ischemic or hemorrhagic stroke with unilateral cortical lesion, confirmed by brain imaging (Computed Tomography or Magnetic Resonance Imaging).
- •Subacute phase of stroke (from day 8 post-ictus up to 6 months after stroke onset).
- •Hemodynamically stable. Glasgow Coma Scale score of 13, enabling participation in the intervention protocol.
- •Signed Informed Consent Form provided by the participant or their legally authorized representative.
Exclusion Criteria
- •Patients who underwent surgical intervention due to stroke. Presence of electronic devices or metallic implants in the skull or cervical region.
- •History of recent seizures or uncontrolled epilepsy. Presence of other neurological diseases associated with stroke (e.g., Alzheimer's disease, Parkinson's disease).
- •History of multiple previous strokes. Dysphagia resulting from other etiologies, such as cervical trauma or head and neck neoplasms.
- •Cognitive impairment preventing proper participation in the proposed intervention protocol.
- •Occurrence of any allergic reaction or adverse effect related to transcranial direct current stimulation (tDCS).
Outcomes
Primary Outcomes
ACompare the effectiveness of the intervention
Time Frame: Ten days
Evaluate swallowing in participants by comparing time measurements on the first day, fifth day, and tenth day of intervention.
Secondary Outcomes
No secondary outcomes reported
Investigators
Juliane Lisboa Pereira
Juliane Lisboa Pereira
Universidade do Estado do Pará