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Effect of Transcranial Stimulation associated with Speech Therapy on swallowing in the acute phase of Stroke

Effect of Transcranial Direct Current Stimulation associated with Speech Therapy on Swallowing in the acute phase of Stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-72n9y83
Enrollment
Unknown
Registered
2023-04-13
Start date
2022-04-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deglutition Disorders

Interventions

E02.331.750
Study participants were randomly assigned, in a 1:1 ratio, to one of the study groups - intervention (anodic stimulation) or sham (control) through a randomization scheme generated by the Randomizatio

Sponsors

Universidade Federal do Triângulo Mineiro
Lead Sponsor
Universidade Federal do Triângulo Mineiro
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients diagnosed with ischemic stroke for a maximum of 72 hours (acute phase) will be included; confirmed by computed tomography or magnetic resonance imaging; after neurological evaluation; of both sexes; over the age of 18 years; with dysphagia

Exclusion criteria

Exclusion criteria: Individuals with great swallowing impairment before stroke were excluded; previous episodes of stroke; previous dysphagia; associated neurological pathologies; any metal in the cranial cavity; lesions in the area of electrode placement (some skin change in the scalp in the area to be stimulated); metal in use of pacemaker; previous skull surgery; eyes or decompression surgery; use of medications that interfere with cortical excitability (opiates; benzodiazepines); score above 8 on the hospital scale of anxiety and depression (HAD); uncontrolled epileptic seizure; in addition to clinical instability (systolic blood pressure; drop in systolic blood pressure; heart rate; altered consciousness; cold and sticky skin); severe cognitive impairment; global aphasia; previous visual disturbances; ; other associated neurological diseases or possibility of pregnancy

Design outcomes

Primary

MeasureTime frame
It is expected to find a reduction in the degree of severity of dysphagia in subjects with stroke, in the acute phase, for a period of 06 months, verified through the application of transcranial stimulation by direct current, associated with speech therapy, from the observation of a variation of at least 10% in the pre- and post-intervention measurements.

Secondary

MeasureTime frame
It is expected to find a reduction in the time of use of the alternative feeding route in subjects with stroke in the acute phase for a period of 06 months, verified through the application of transcranial stimulation by direct current, associated with speech therapy, from the observation of a variation of at least 10% in the pre- and post-intervention measurements.;It is expected to find a reduction in the degree of neurological deficits through the National Institute of Health Stroke Scale (NIHSS), which is a standard, validated, safe, quantitative scale of the severity and magnitude of neurological deficit after stroke, that will be applied to the subjects in the acute phase, for a period of 03 consecutive days, verified through the application of transcranial stimulation by direct current, associated with speech therapy, from the observation of a variation of at least 10% in the pre- and post-intervention measurements.;It is expected to find an improvement in quality of life through the instrument Quality of Life in Swallowing Disorders (SWAL-QOL), which is a sensitive self-assessment instrument that allows to know the real impact of the changes experienced at the time of feeding and the perception of the individual about the quality of life in swallowing. This protocol will be applied in subjects with stroke, in the acute phase for a period of 03 consecutive days, through the application of transcranial stimulation by direct current, associated with speech therapy, from the observation of a variation of at least 10% in the pre- and post-intervention measurements.;It is expected to find a reduction in the costs and expenses with hospitalization time due to aspiration pneumonia, in the subjects with stroke, in the acute phase, for a period of 06 months, verified through the application of transcranial stimulation by direct current, associated with speech therapy, from the observation of a variation of at least 10% in the pre- and post-intervention measurements.

Countries

Brazil

Contacts

Public ContactLuciana dos Santos Rabelo

Universidade Federal do Triângulo Mineiro

cep.hctm@ebserh.gov.br+55 343318-5319

Outcome results

None listed

Source: REBEC (via WHO ICTRP)