StrokeNCT07732673
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
A study testing tDCS in people with Stroke and Dysphagia, run by Juliane Lisboa Pereira at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Jul 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- tDCS, tDCS Sham
- Keywords
- Stroke, Dysphagia, tDCS
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Active tDCS + Swallowing rehabilitation
tDCS ShamDevice
Sham tDCS + Swallowing rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Sham tDCS Receives: Device: tDCS Sham |
| Experimental Group | Experimental | Active tDCS Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACompare the effectiveness of the intervention
Evaluate swallowing in participants by comparing time measurements on the first day, fifth day, and tenth day of intervention.
Measured: Ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start16 Jul 2026
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juliane Lisboa Pereira
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Estado do Para
- Responsible party
- Sponsor-investigator, Juliane Lisboa Pereira, Universidade do Estado do Pará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732673
- Sponsor's protocol ID
- CAAE: 97597526.4.0000.8767
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07732673
- Acronym / sponsor ID
- CAAE: 97597526.4.0000.8767
- Keywords
- Stroke, Dysphagia, tDCS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Juliane Lisboa PereiraUniversity, hospital or other
- Collaborators
- Universidade do Estado do Para
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Device: tDCS ShamSham tDCS |
| Experimental Group | Experimental | Device: tDCSActive tDCS |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSActive tDCS + Swallowing rehabilitation | Device | Experimental Group |
| tDCS ShamSham tDCS + Swallowing rehabilitation | Device | Control Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Stroke and Dysphagia, run by Juliane Lisboa Pereira at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACompare the effectiveness of the intervention (time frame: Ten days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.