Investigating the effectiveness of transcranial Direct Current Stimulation (tDCS) on the swallowing function of the patients with post – stroke dysphagia
Investigating the effectiveness of transcranial Direct Current Stimulation (tDCS) on the swallowing function of the patients with post – stroke dysphagia
Design
A parallel group, concealed, double blinded, randomised sham controlled clinical trial with with 44 participants.
Settings and conduct
The study will be conducted in Shiraz University of Medical Sciences hospitals. Stroke patients will be screened and assessed and if they get the eligibility for the study they will put into control or experimental group. Then they will get intervention for 5 days and again will be assessed exactly after treatment and one month later.
Participants/Inclusion and exclusion criteria
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:
Presence of Hemorrhagic or Lacunar stroke.
Previous history of dysphagia.
Presence of neurological disorders other than stroke or neurodegenerative disorders.
Presence of severe uncontrollable medical conditions.
Auditory and Visual Conditions which can interfere with the intervention process.
History of seizures.
Having cardiac pacemaker or metallic implants.
Previous or current need for skull surgery.
Presence of a tracheal cannula.
Unstable medical condition which can interfere with the study process.
Inability to stay alert during treatment.
Intervention groups
The experimental group: The participants will receive both behavioral treatment and tDCS.
The control group: The participants will receive the behavioral treatment and sham of tDCS
Main outcome variables
The functional oral intake; dysphagia severity; aspiration severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200520047521N1
Registration date:2020-10-30, 1399/08/09
Registration timing:prospective
Last update:2020-10-30, 1399/08/09
Update count:1
Registration date
2020-10-30, 1399/08/09
Registrant information
Name
Sima Farpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3639 9507
Email address
sima.farpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of transcranial Direct Current Stimulation (tDCS) on the swallowing function of the patients with post – stroke dysphagia
Public title
Effectiveness of transcranial Direct Current Stimulation (tDCS) in the patients with post – stroke dysphagia
Purpose
Treatment
Inclusion/Exclusion criteria
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:
Presence of Hemorrhagic or Lacunar stroke.
Previous history of dysphagia.
Presence of neurological disorders other than stroke or neurodegenerative disorders.
Presence of severe uncontrollable medical conditions.
Auditory and Visual Conditions which can interfere with the intervention process.
History of seizures.
Having cardiac pacemaker or metallic implants.
Previous or current need for skull surgery.
Presence of a tracheal cannula.
Unstable medical condition which can interfere with the study process.
Inability to stay alert during treatment.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
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 envelopes by a secretary for concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding participants: All participants will receive behavioral swallowing therapy. tDCS will be montage for all participants. The experimental group will receive 20 minutes of stimulation while the control group will receive sham tDCS and the device will be off after 30 seconds.
Blinding care providers, investigators and outcome assessor: setting the time of tDCS stimulation will be done by a person who is not involved in behavioral therapy or in outcome assessment. The group of patient will be informed to him/her by the secretary via an envelope.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman neuroscience research center, No.1 Alley, Jahad Ave., Somayye crossroad
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2020-09-07, 1399/06/17
Ethics committee reference number
IR.KMU.REC.1399.366
Health conditions studied
1
Description of health condition studied
DYSPHAGIA POST- STROKE
ICD-10 code
R13
ICD-10 code description
Aphagia and dysphagia
Primary outcomes
1
Description
The feeding status of the patient with the Functional Oral Intake Scale (FOIS)
Timepoint
before intervention, exactly after intervention, one month after intervention
Method of measurement
Functional Oral Intake Scale (FOIS)
Secondary outcomes
1
Description
the severity of dysphagia and aspiration
Timepoint
before intervention, exactly after intervention, one month after intervention
Method of measurement
The MANN assessment of swallowing ability (MASA)
Intervention groups
1
Description
Intervention group: tDCS online with classic (behavioural) swallowing therapy for 20 minutes in five days
Category
Rehabilitation
2
Description
Control group: Sham tDCS online with classic (behavioural) swallowing therapy for 20 minutes in five days
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Dr. Afshin Borhani Haghighi
Street address
Namzi hospital, Zand street
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
neuro.ab@gmail.com
2
Recruitment center
Name of recruitment center
Shahid Faghihi hospital
Full name of responsible person
Dr. Afshin Borhani Haghighi
Street address
Shahid Fagihi, Zand street
City
Shiraz
Province
Fars
Postal code
71348 46316
Phone
+98 71 3484 6316
Email
neuro.ab@gmail.com
3
Recruitment center
Name of recruitment center
Shahid Rajaee (Emtyaz) hospital
Full name of responsible person
Dr. Hamidreza Farpour
Street address
Shahid Chamran Blv.
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
farporh@gmail.com
4
Recruitment center
Name of recruitment center
Shahid Chamran hospital
Full name of responsible person
Dr. Hamidreza Farpour
Street address
Shahid Chamran Blv.
City
Shiraz
Province
Fars
Postal code
1564471948
Phone
+98 71 3624 0101
Email
farporh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Majid Asady Shekary
Street address
Kerman neuroscience, research center, Alley 1, Jahad Ave, Somayye crossroad,
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3787
Email
m_asady@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?