Protocol summary
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Study aim
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Investigating the effectiveness of transcranial direct current stimulation (TDCS) on the swallowing function of the patients with post–stroke dysphagia
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Design
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A double blinded concealed clinical trial, parallel group, randomized, with 48 participants and control group.
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Settings and conduct
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The study will be conducted in Shiraz University of Medical Sciences hospitals. Stroke patients will be screened and assessed and will put into control or experimental group. They will get intervention for 5 sessions and will be assessed one day after the last day of intervention and one month later.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age 18 or over.Presence of ischemic stroke confirmed with brain imaging.
having dysphagia according to Northwestern Dysphagia Patient Checksheet Screening tool (NDPCS).
Exclusion criteria:
Hemorrhagic or Lacunar stroke.Previous history of dysphagia.
Presence of neurological disorders other than stroke or neurodegenerative disorders.Auditory and Visual Condition interfering with a speech therapist or assessor orTDCS technician s instruction. History of seizures.
Those with a cardiac pacemaker or metallic implants. Previous history of skull surgery or current need of skull surgery. Presence of a tracheal cannula.
Unstable medical condition which can interfere with the study process (such as hemodynamic instability, decreased level of consciousness, etc.) Inability to stay alert during the treatment. For the safety of both patients and the research group, none of the patients recruited for the study had active SARS-COV-2 infections or a history of infection in the last 14 days.
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Intervention groups
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The experimental group will receive both behavioral treatment and TDCS.
The control group will receive the behavioral treatment and the sham TDCS
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Main outcome variables
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The functional oral intake; dysphagia severity; aspiration severity
General information
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Reason for update
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Dictation mistakes, Add some example/sentences for more clarification
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200520047521N1
Registration date:
2020-10-30, 1399/08/09
Registration timing:
prospective
Last update:
2022-05-28, 1401/03/07
Update count:
1
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Registration date
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2020-10-30, 1399/08/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-11-20, 1399/08/30
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Expected recruitment end date
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2022-05-21, 1401/02/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effectiveness of transcranial direct current stimulation (TDCS) on the swallowing function of the patients with post – stroke dysphagia
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Public title
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Effectiveness of transcranial direct current stimulation (TDCS) in the patients with post – stroke dysphagia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 18 years or over.
Presence of ischemic stroke confirmed with brain imaging.
diagnosis of dysphagia according to Northwestern Dysphagia Patient Checksheet Screening tool (NDPCS).
Exclusion criteria:
Hemorrhagic or Lacunar stroke.
Previous history of dysphagia.
Presence of neurological disorders other than stroke or neurodegenerative disorders.
Auditory and Visual Condition interfering with a speech therapist or assessor orTDCS technician s instruction
History of seizures.
Those with a cardiac pacemaker or metallic implants.
Previous history of skull surgery or current need of skull surgery.
Presence of a tracheal cannula.
Unstable medical condition which can interfere with the study process (such as hemodynamic instability, decreased level of consciousness, etc.)
Inability to stay alert during the treatment.
This study was done during the COVID- 19 pandemic. For the safety of both patients and the research group, none of the patients recruited for the study had active SARS- COV- 2 infections or a history of infection in the last 14 days.
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Stratified randomisation using permuted blocked randomisation in each group.
With random allocation software.
Severity of dysphagia and severity of stroke will be used for grouping.
Using sealed envelopes by a secretary for concealment.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Blinding participants/ families/ caregivers: All participants will receive behavioral swallowing therapy and TDCS stimulation. For the sham group (control group) the same montage of TDCS will be performed. The only difference is that the real group (experimental group) will receive 20 minutes of TDCS stimulation while the sham group will receive the current only for 30 seconds at the begining and the end of the period .
Blinding care providers (speech therapist, and stroke physicians), investigators and outcome assessor: The TDCS technician will be trained and employed to deliver the TDCS . The technician will be independent of the investigators and will be unaware of the study’ methodology. The secretary will inform them about the group of the patients (real or sham TDCS) in a sealed envelope. Therefore, the only persons who will know the group of the patients (sham or real) will be the secretary and the technician of TDCS.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-09-07, 1399/06/17
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Ethics committee reference number
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IR.KMU.REC.1399.366
Health conditions studied
1
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Description of health condition studied
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DYSPHAGIA POST- STROKE
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ICD-10 code
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R13
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ICD-10 code description
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Aphagia and dysphagia
Primary outcomes
1
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Description
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The feeding status of the patient with the Functional Oral Intake Scale (FOIS)
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Timepoint
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before intervention, one day after the last day of intervention, one month after intervention
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Method of measurement
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Functional Oral Intake Scale (FOIS)
Secondary outcomes
1
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Description
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the severity of dysphagia and aspiration
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Timepoint
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before intervention, one day after the last day of intervention, one month after intervention
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Method of measurement
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The MANN assessment of swallowing ability (MASA)
Intervention groups
1
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Description
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Intervention group: TDCS online with classic (behavioral) swallowing therapy for 20 minutes in five therapy sessions (1 session each day)
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Category
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Rehabilitation
2
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Description
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Control group: Sham TDCS online with classic (behavioural) swallowing therapy for 20 minutes in five therapy sessions (1 session each day)
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kerman University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All participant data will be shared after the encoding including age, sex, dysphagia severity, test results and research implementation method.
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When the data will become available and for how long
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Six month after publication the results will be shared.
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To whom data/document is available
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All researchers.
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Under which criteria data/document could be used
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To use in meta- analysis studies or citation data in other relevant studies.
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From where data/document is obtainable
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Sima Farpour
email: sima.farpour@gmail.com
Mobile: 0098 9173177636
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What processes are involved for a request to access data/document
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By formal request via email and the purpose of using data, the information will be sent.
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Comments
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