DysphagiaNCT04308733
tDCS for Dysphagia Associated to Brainstem Stroke
A study testing Anodal tDCS in people with Dysphagia, run by Presidio Ospedaliero Garibaldi-Centro at 1 site in Italy.
Trial summary
The aim of the study is to investigate the effect of anodal transcranial direct current stimulation applied over the pharyngeal motor area in 60 dysphagic patients with acute isolated brainstem stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Anodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 30 Mar 2020to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- accepting to participating to the study
- age not < 18 years
- bulbar stroke occurring within the previous 24 hours
Who cannot join
- age < 18 years
- inability to give informed consent because of cognitive impairment
- stroke occurring over the previous 24 hours
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Domenico A. Restivo
Catania, 95100
Domenico A Restivo, MD, PhD, +39 095 7593909, darestivo@libero.it
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) for Patients With Oro-pharyngeal Dysphagia Associated to Brainstem Stroke
The aim of the study is to investigate the effect of anodal transcranial direct current stimulation applied over the pharyngeal motor area in 60 dysphagic patients with acute isolated brainstem stroke. Thirty patients will undergo stimulation on the pharyngeal area contralateral to the side of brainstem lesion, and 30 patients will receive sham stimulation over the contralateral area, for 4 consecutive days. Patients will be re-evaluated after 4 consecutive days of stimulation. Primary outcome: The Penetration/Aspiration Scale after 4 consecutive days of stimulation. Secondary outcomes: changes in electromyographic parameters and pharyngeal cortical motor evoked potentials, changes in the Dysphagia Severity Rating Scale (DSRS), in the Functional Oral Intake Scale (FOIS), and in the "Dysphagia Limit Test", after 4 consecutive days of stimulation.
Read the detailed description
Sixty consecutive patients with dysphagia associated to isolated acute (within the previous 24 hours) brainstem ischemic stroke satisfying the inclusion/exclusion criteria will be enrolled.
Swallowing evaluation Clinical evaluation comprises fiberoptic endoscopy that will be used for scoring the Penetration/Aspiration Scale. The Penetration/Aspiration Scale will be scored by two otolaryngologists and one neurologist blinded to the patient's study group allocation. Moreover, feeding status will be evaluated by the clinical "Dysphagia Severity Rating Scale", ranging from 0 (normal fluids, normal diet, and eating independently) to 12 (no oral fluids, no oral feeding). Moreover the "Functional Oral Intake Scale", ranging from 1 (nothing by mouth) to 7 (total oral diet with no restriction), and the "Dysphagia Limit Test", evaluating the amount of water that can be swallowed without piece-meal deglutition or clinical signs of aspiration, will be used in patient evaluation. Piecemeal deglutition will be evaluated both clinically and by means of electromyographic recordings from the mouth floor muscles. Moreover, simultaneous electromyographic/mechanographic recordings from the above mentioned muscles, as well as from cricopharyngeal muscle and from the thyroid cartilage will be also performed. The changes in cortico-pharyngeal excitability will be evaluated by recording motor evoked potentials from the pharyngeal muscles after transcranial magnetic stimulation.
Randomization: patients will be randomly assigned to either the active treatment (real) or sham groups according to a computer-generated list. Randomization will be stratified in order to match age, and severity of dysphagia.
Transcranial direct current stimulation: anodal transcranial direct current stimulation will be delivered through two 25-cm2 rectangular surface electrodes, with the active one placed over the "pharyngeal" area of the motor cortex contralateral to the side of brainstem lesion and the reference one on the contralateral supraorbital ridge. Furthermore, the electrodes will be fixed in their position using a set of adjustable rubber straps placed around the head. For the active intervention (the "real" stimulation group), current intensity will be slowly increased up to 2mA. This intensity will be maintained for 20 min before the stimulation will be slowly turned off over a 10-sec period. For the "sham" intervention, the current will be left on only for 30 sec, while the electrodes will be left in place for a further 20-min period. All patients will be evaluated at baseline, and after 4 consecutive days of stimulation.
- Conditions
- Dysphagia
- Being tested
- Anodal tDCS
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
patients will be stimulated over the contralateral pharyngeal motor cortex with anodal tDCS (2mA, 20 minutes) for 4 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| real tDCS | Active comparator | 30 patients will be treated with real anodal tDCS over the contralateral pharyngeal motor cortex Receives: Device: Anodal tDCS |
| sham tDCS | Sham comparator | 30 patients will be treated with sham tDCS over the contralateral pharyngeal motor cortex Receives: Device: Anodal tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration Aspiration Scale (PAS)
PAS is an 8-point severity scale from 1 = no material enters the airways to 8 = material enters the airways, passes below the vocal folds in the absence of any effort to eject it.
Measured: Change from baseline PAS at 4 days
Secondary outcomes (4)
Functional Oral Intake Scale (FOIS)
FOIS is a scale ranging from 1 (nothing by mouth) to 7 (total oral diet with no restriction)
Measured: Change from baseline FOIS at 4 days
Dysphagia Limit Test
The "Dysphagia Limit Test", evaluates the amount of water that can be swallowed without piece-meal deglutition or clinical signs of aspiration.
Measured: Change from baseline "Dysphagia Limit Test" at 4 days
Pharyngeal (motor evoked potentials (MEPs) after Transcranial Magnetic Stimulation (TMS)
the changes in amplitude of MEPs recorded from pharyngeal muscle after TMS over the pharyngeal contralateral motor cortex will be evaluated
Measured: Change from baseline pharyngeal MEPs at 4 days
electromyographic/cinematic evaluation of swallowing
Simultaneous electromyographic/cinematic recordings from mouth floor muscles, cricopharyngeal muscle and thyroid cartilage will be performed
Measured: Change from baseline electromyographic/cinematic parameters at 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start30 Mar 2020
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Presidio Ospedaliero Garibaldi-Centro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Domenico Antonio Restivo, Presidio Ospedaliero Garibaldi-Centro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308733
- Sponsor's protocol ID
- Restivo Domenico
- Status last verified
- Sep 2020
- First submitted
- 8 Mar 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) for Patients With Oro-pharyngeal Dysphagia Associated to Brainstem Stroke
- ClinicalTrials.gov ID
- NCT04308733
- Acronym / sponsor ID
- Restivo Domenico
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Presidio Ospedaliero Garibaldi-CentroUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 16 Mar 2020 (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 aim of the study is to investigate the effect of anodal transcranial direct current stimulation applied over the pharyngeal motor area in 60 dysphagic patients with acute isolated brainstem stroke. Thirty patients will undergo stimulation on the pharyngeal area contralateral to the side of brainstem lesion, and 30 patients will receive sham stimulation over the contralateral area, for 4 consecutive days. Patients will be re-evaluated after 4 consecutive days of stimulation. Primary outcome: The Penetration/Aspiration Scale after 4 consecutive days of stimulation. Secondary outcomes: changes in electromyographic parameters and pharyngeal cortical motor evoked potentials, changes in the Dysphagia Severity Rating Scale (DSRS), in the Functional Oral Intake Scale (FOIS), and in the "Dysphagia Limit Test", after 4 consecutive days of stimulation.
Detailed description
Sixty consecutive patients with dysphagia associated to isolated acute (within the previous 24 hours) brainstem ischemic stroke satisfying the inclusion/exclusion criteria will be enrolled.
Swallowing evaluation Clinical evaluation comprises fiberoptic endoscopy that will be used for scoring the Penetration/Aspiration Scale. The Penetration/Aspiration Scale will be scored by two otolaryngologists and one neurologist blinded to the patient's study group allocation. Moreover, feeding status will be evaluated by the clinical "Dysphagia Severity Rating Scale", ranging from 0 (normal fluids, normal diet, and eating independently) to 12 (no oral fluids, no oral feeding). Moreover the "Functional Oral Intake Scale", ranging from 1 (nothing by mouth) to 7 (total oral diet with no restriction), and the "Dysphagia Limit Test", evaluating the amount of water that can be swallowed without piece-meal deglutition or clinical signs of aspiration, will be used in patient evaluation. Piecemeal deglutition will be evaluated both clinically and by means of electromyographic recordings from the mouth floor muscles. Moreover, simultaneous electromyographic/mechanographic recordings from the above mentioned muscles, as well as from cricopharyngeal muscle and from the thyroid cartilage will be also performed. The changes in cortico-pharyngeal excitability will be evaluated by recording motor evoked potentials from the pharyngeal muscles after transcranial magnetic stimulation.
Randomization: patients will be randomly assigned to either the active treatment (real) or sham groups according to a computer-generated list. Randomization will be stratified in order to match age, and severity of dysphagia.
Transcranial direct current stimulation: anodal transcranial direct current stimulation will be delivered through two 25-cm2 rectangular surface electrodes, with the active one placed over the "pharyngeal" area of the motor cortex contralateral to the side of brainstem lesion and the reference one on the contralateral supraorbital ridge. Furthermore, the electrodes will be fixed in their position using a set of adjustable rubber straps placed around the head. For the active intervention (the "real" stimulation group), current intensity will be slowly increased up to 2mA. This intensity will be maintained for 20 min before the stimulation will be slowly turned off over a 10-sec period. For the "sham" intervention, the current will be left on only for 30 sec, while the electrodes will be left in place for a further 20-min period. All patients will be evaluated at baseline, and after 4 consecutive days of stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tDCS | Active comparator | Device: Anodal tDCS30 patients will be treated with real anodal tDCS over the contralateral pharyngeal motor cortex |
| sham tDCS | Sham comparator | Device: Anodal tDCS30 patients will be treated with sham tDCS over the contralateral pharyngeal motor cortex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- accepting to participating to the study
- age not < 18 years
- bulbar stroke occurring within the previous 24 hours
Key exclusion criteria (3 listed)
- age < 18 years
- inability to give informed consent because of cognitive impairment
- stroke occurring over the previous 24 hours
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 |
|---|---|---|
| Anodal tDCSpatients will be stimulated over the contralateral pharyngeal motor cortex with anodal tDCS (2mA, 20 minutes) for 4 consecutive days | Device | real tDCS, sham tDCS |
Primary outcome
Penetration Aspiration Scale (PAS)
Time frame: Change from baseline PAS at 4 days
PAS is an 8-point severity scale from 1 = no material enters the airways to 8 = material enters the airways, passes below the vocal folds in the absence of any effort to eject it.
4 secondary outcomes
Functional Oral Intake Scale (FOIS)
Time frame: Change from baseline FOIS at 4 days
Dysphagia Limit Test
Time frame: Change from baseline "Dysphagia Limit Test" at 4 days
Pharyngeal (motor evoked potentials (MEPs) after Transcranial Magnetic Stimulation (TMS)
Time frame: Change from baseline pharyngeal MEPs at 4 days
electromyographic/cinematic evaluation of swallowing
Time frame: Change from baseline electromyographic/cinematic parameters at 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS in people with Dysphagia, run by Presidio Ospedaliero Garibaldi-Centro at 1 site in Italy.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Sep 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Domenico A Restivo, MD, PhD (+39 095 7593909, darestivo@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration Aspiration Scale (PAS) (time frame: Change from baseline PAS at 4 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 16 Sep 2020.