StrokeNCT06213597
Effects of Repetitive Transcranial Magnetic Stimulation on Patients With Dysphagia in Stroke Observed Based on Functional Near-infrared Spectroscopic
A study testing routine swallowing rehabilitation and real repetitive transcranial magnetic stimulation in people with Stroke and Deglutition Disorders, run by Ruyao Liu at 1 site in China.
Trial summary
This trial was a randomized, double-blind, sham-controlled trial.Thirty patients with post-stroke dysphagia were randomly assigned to the repetitive transcranial magnetic stimulation(rTMS) group (n=15) or sham rTMS group (n=15). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Deglutition Disorders
- What is being tested?
- routine swallowing rehabilitation and real repetitive transcranial magnetic stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2023to 8 Jan 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years of age, right-handed;
- unilateral stroke, diagnosed by cranial MRI or CT;
- disease duration of 2 weeks to 6 months;
- dysphagia confirmed by the Videofluoroscopic swallowing study;
- patient's vital signs were stable;
- consciousness was clear, able to cooperate in completing the rehabilitation therapy, assessment, and the fNIRS test;
- cranial bone was intact without craniotomy and/or craniovertebral repair;
- the subject signed the Declaration of Helsinki according to the Informed consent.
Who cannot join
- previous dysphagia due to other diseases such as Parkinson's disease, dementia, or the presence of organic swallowing dysfunction;
- contraindications to rTMS: stimulation coils or the presence of a metal foreign body near the stimulated scalp, built-in pulse generators, cardiac stents, cardiac bypass grafting, etc;
- previous history of psychiatric disease or epilepsy;
- pregnancy;
- skin infection or breakage on the head;
- previous or current stroke, traumatic brain injury and other neurological or mental system diseases;
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- serious cardiac, pulmonary, hepatic, renal dysfunction, malignant tumors, serious complications;
- poor patient compliance and evaluation,other neurological or psychiatric disorders;
- severe cardiac, pulmonary, hepatic, or renal dysfunction, malignant tumors, and serious complications;
- poor patient compliance and non-cooperation with treatment and evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of zhengzhou university
Zhengzhou, Henan, 450000
About this study
Official title: Effects of Healthy-side High-frequency Repetitive Transcranial Magnetic Stimulation in Patients With Post Stroke Dysphagia: a Prospective Study Based on Functional Near-infrared Spectroscopic
This trial was a randomized, double-blind, sham-controlled trial.Thirty patients with post-stroke dysphagia were randomly assigned to the repetitive transcranial magnetic stimulation(rTMS) group (n=15) or sham rTMS group (n=15). Both groups received conventional swallowing rehabilitation, and in addition, the rTMS group received 5hz repetitive transcranial magnetic stimulation on the healthy side. Swallowing function was assessed at admission and after two weeks of treatment using the the Standardized Swallowing Assessment (SSA), the Penetration-Aspiration Scale (PAS), the Fiberoptic Endoscopic Dysphagia Severity Scale(FEDSS), the Functional Oral Intake Scale (FOIS), and the functional near-infrared spectroscopic(fNIRS).
Read the detailed description
Stroke is the leading cause of death and disability worldwide, and dysphagia is one of the common complications of stroke.Dysphagia after stroke can lead to serious complications such as aspiration, pneumonia, and malnutrition, which greatly reduces the quality of life of patients.Transcranial magnetic stimulation(TMS), a non-invasive central nervous system stimulation that is safe, non-invasive, and does not require active patient participation, has been gradually applied to stroke rehabilitation in recent years.Although there have been studies on the improvement of post stroke dysphagia(PSD) by healthy-side high-frequency rTMS, there have been no studies assessing the activation of relevant brain regions before and after its treatment by fNIRS and exploring the possible mechanisms involved. The aim of this study was to observe the effect of high-frequency rTMS stimulation of the healthy mandibular hyoid cortical area at 5 hz on PSD, and to explore the possible mechanisms by assessing it with fNIRS, so as to provide a theoretical basis for the clinical use of rTMS in the treatment of patients with PSD.
- Conditions
- Stroke, Deglutition Disorders
- Being tested
- routine swallowing rehabilitation, real repetitive transcranial magnetic stimulation, sham repetitive transcranial magnetic stimulation
- 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.
routine swallowing rehabilitationOther
Routine swallowing rehabilitation training mainly included oral and facial muscle training, ice stimulation therapy, Mendelssohn maneuver training, and tongue root resistance training. The subjects were treated twice a day, Monday through Saturday, for 20 min each time for 2 weeks. All operations were performed by the same trained and qualified professional rehabilitation therapist.
real repetitive transcranial magnetic stimulationDevice
In the rTMS group, 5 Hz rTMS was applied to the hot spot of the supraglottic motor cortex of the affected hemisphere at a treatment intensity of 80% resting motor threshold for 10 min, with a total of 250 pulses (with an interval of 11 s for every 1 s of continuous stimulation), and the treatment was performed once a day for 6 d per week for 2 weeks.
sham repetitive transcranial magnetic stimulationDevice
The sham rTMS group supplemented pseudomagnetic stimulation at the hotspot of the representative area, tilted the magnetic stimulation coil at 90°, and the same noise was emitted by the instrument during the treatment, but no stimulation was performed, and the group was treated once a day, 6d per week, for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| repetitive transcranial magnetic stimulation group | Experimental | Randomization was performed by a staff member of our hospital, who was not involved in the implementation or evaluation of the trial, and who randomly assigned subjects to either the rTMS group or the sham rTMS group in a 1:1 ratio through the use of an electronic random sequence generator. Opaque, sealed envelopes were used to mask the randomization tables. Receives: Other: routine swallowing rehabilitation; Device: real repetitive transcranial magnetic stimulation |
| sham repetitive transcranial magnetic stimulation | Sham comparator | Randomization was performed by a staff member of our hospital, who was not involved in the implementation or evaluation of the trial, and who randomly assigned subjects to either the rTMS group or the sham rTMS group in a 1:1 ratio through the use of an electronic random sequence generator. Opaque, sealed envelopes were used to mask the randomization tables. Receives: Other: routine swallowing rehabilitation; Device: sham repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Swallowing Assessment
SSA: consists of 3 parts, scoring 18-46 points: clinical evaluation, including consciousness, lip control and other seven items, total score 8-23 points; take about 5ml of water for the patient to swallow, repeat 3 times, the corner of the mouth with or without water, swallowing with or without laryngeal movement to observe the situation, the total score of 5-11 points; the first two items are normal, the amount of water was increased to about 60 ml, and whether the drink can be completed the whole situation, the total score of 5-12 points. The total score is 5~12. The higher the score, the more serious the swallowing disorder.
Measured: day 1 and day 14
Secondary outcomes (4)
Penetration-Aspiration Scale
PAS: An 8-point scale reflecting airway invasion, taking the highest score of airway infiltration (contrast entering the laryngeal vestibule) and aspiration (contrast entering below the true vocal folds) during each swallow: 1 means that the food did not enter the airway, and 8 means that the food reached below the vocal folds of the airway and could not be cleared. the higher the score, the worse the dysphagia of the patients.
Measured: day 1 and day 14
Fiberoptic Endoscopic Dysphagia Severity Scale
FEDSS: A scale based on the results of the Flexible Endoscopic Evaluation of Swallowing (FEES) examination. Under the flexible endoscope, the patient's salivary secretion is observed. The patient then eats 3 different textures of food, i.e., soft solids, liquids, or pudding.The FEDSS scale is scored from 1 to 6, with a maximum score of 1 and a minimum score of 6. These scores are based on the risk of foods with different dietary consistencies and salivary penetration or aspiration observed during endoscopy.
Measured: day 1 and day 14
Functional Oral Intake Scale
FOIS: 7 levels based on safety and efficiency: Level 1: No oral intake. Level 2: Tube-dependent feeding, minimizing attempts to ingest food or liquids. Level 3: Tube-dependent feeding, with single-textured foods or liquids fed by mouth. Level 4: Single textured food given exclusively by mouth. Level 5: Complete oral administration of a variety of textures, but requires special preparation or compensation. level 6: Complete oral feeding without special preparation, but with special food restrictions. Level 7: Complete oral feeding with no restrictions.
Measured: day 1 and day 14
Functional near-infrared spectroscopy
After the subjects entered the fNIRS evaluation room, they sat comfortably for 5 min and then wore the fNIRS head cap. Subjects were instructed to perform repetitive salivary swallowing maneuvers for 30s, and resting-state acquisition for 30s before and after completion of the swallowing maneuvers, and were instructed to sit in a relaxed position and to avoid moving and thinking.
Measured: day 1 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start28 May 2023
- Primary completion25 Dec 2023
- Study completion8 Jan 2024
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, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruyao Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruyao Liu, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Xi Zeng, Study chair, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213597
- Sponsor's protocol ID
- 2020-PT310-02
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and analyzed during the current study are not publicly available due to the hospital's confidentiality regulations regarding trial data but are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Healthy-side High-frequency Repetitive Transcranial Magnetic Stimulation in Patients With Post Stroke Dysphagia: a Prospective Study Based on Functional Near-infrared Spectroscopic
- ClinicalTrials.gov ID
- NCT06213597
- Acronym / sponsor ID
- 2020-PT310-02
- Conditions
- Stroke, Deglutition Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ruyao LiuUniversity, hospital or other
- Study start
- 28 May 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 19 Jan 2024 (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.
This trial was a randomized, double-blind, sham-controlled trial.Thirty patients with post-stroke dysphagia were randomly assigned to the repetitive transcranial magnetic stimulation(rTMS) group (n=15) or sham rTMS group (n=15). Both groups received conventional swallowing rehabilitation, and in addition, the rTMS group received 5hz repetitive transcranial magnetic stimulation on the healthy side. Swallowing function was assessed at admission and after two weeks of treatment using the the Standardized Swallowing Assessment (SSA), the Penetration-Aspiration Scale (PAS), the Fiberoptic Endoscopic Dysphagia Severity Scale(FEDSS), the Functional Oral Intake Scale (FOIS), and the functional near-infrared spectroscopic(fNIRS).
Detailed description
Stroke is the leading cause of death and disability worldwide, and dysphagia is one of the common complications of stroke.Dysphagia after stroke can lead to serious complications such as aspiration, pneumonia, and malnutrition, which greatly reduces the quality of life of patients.Transcranial magnetic stimulation(TMS), a non-invasive central nervous system stimulation that is safe, non-invasive, and does not require active patient participation, has been gradually applied to stroke rehabilitation in recent years.Although there have been studies on the improvement of post stroke dysphagia(PSD) by healthy-side high-frequency rTMS, there have been no studies assessing the activation of relevant brain regions before and after its treatment by fNIRS and exploring the possible mechanisms involved. The aim of this study was to observe the effect of high-frequency rTMS stimulation of the healthy mandibular hyoid cortical area at 5 hz on PSD, and to explore the possible mechanisms by assessing it with fNIRS, so as to provide a theoretical basis for the clinical use of rTMS in the treatment of patients with PSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| repetitive transcranial magnetic stimulation group | Experimental | Other: routine swallowing rehabilitation, Device: real repetitive transcranial magnetic stimulationRandomization was performed by a staff member of our hospital, who was not involved in the implementation or evaluation of the trial, and who randomly assigned subjects to either the rTMS group or the sham rTMS group in a 1:1 ratio through the use of an electronic random sequence generator. Opaque, sealed envelopes were used to mask the randomization tables. |
| sham repetitive transcranial magnetic stimulation | Sham comparator | Other: routine swallowing rehabilitation, Device: sham repetitive transcranial magnetic stimulationRandomization was performed by a staff member of our hospital, who was not involved in the implementation or evaluation of the trial, and who randomly assigned subjects to either the rTMS group or the sham rTMS group in a 1:1 ratio through the use of an electronic random sequence generator. Opaque, sealed envelopes were used to mask the randomization tables. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 to 80 years of age, right-handed;
- unilateral stroke, diagnosed by cranial MRI or CT;
- disease duration of 2 weeks to 6 months;
- dysphagia confirmed by the Videofluoroscopic swallowing study;
- patient's vital signs were stable;
Key exclusion criteria (10 listed)
- previous dysphagia due to other diseases such as Parkinson's disease, dementia, or the presence of organic swallowing dysfunction;
- contraindications to rTMS: stimulation coils or the presence of a metal foreign body near the stimulated scalp, built-in pulse generators, cardiac stents, cardiac bypass grafting, etc;
- previous history of psychiatric disease or epilepsy;
- pregnancy;
- skin infection or breakage on the head;
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 |
|---|---|---|
| routine swallowing rehabilitationRoutine swallowing rehabilitation training mainly included oral and facial muscle training, ice stimulation therapy, Mendelssohn maneuver training, and tongue root resistance training. The subjects were treated twice a day, Monday through Saturday, for 20 min each time for 2 weeks. All operations were performed by the same trained and qualified professional rehabilitation therapist. | Other | repetitive transcranial magnetic stimulation group, sham repetitive transcranial magnetic stimulation |
| real repetitive transcranial magnetic stimulationIn the rTMS group, 5 Hz rTMS was applied to the hot spot of the supraglottic motor cortex of the affected hemisphere at a treatment intensity of 80% resting motor threshold for 10 min, with a total of 250 pulses (with an interval of 11 s for every 1 s of continuous stimulation), and the treatment was performed once a day for 6 d per week for 2 weeks. | Device | repetitive transcranial magnetic stimulation group |
| sham repetitive transcranial magnetic stimulationThe sham rTMS group supplemented pseudomagnetic stimulation at the hotspot of the representative area, tilted the magnetic stimulation coil at 90°, and the same noise was emitted by the instrument during the treatment, but no stimulation was performed, and the group was treated once a day, 6d per week, for 2 weeks. | Device | sham repetitive transcranial magnetic stimulation |
Primary outcome
Standardized Swallowing Assessment
Time frame: day 1 and day 14
SSA: consists of 3 parts, scoring 18-46 points: clinical evaluation, including consciousness, lip control and other seven items, total score 8-23 points; take about 5ml of water for the patient to swallow, repeat 3 times, the corner of the mouth with or without water, swallowing with or without laryngeal movement to observe the situation, the total score of 5-11 points; the first two items are normal, the amount of water was increased to about 60 ml, and whether the drink can be completed the whole situation, the total score of 5-12 points. The total score is 5~12. The higher the score, the more serious the swallowing disorder.
4 secondary outcomes
Penetration-Aspiration Scale
Time frame: day 1 and day 14
Fiberoptic Endoscopic Dysphagia Severity Scale
Time frame: day 1 and day 14
Functional Oral Intake Scale
Time frame: day 1 and day 14
Functional near-infrared spectroscopy
Time frame: day 1 and day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No. The datasets generated and analyzed during the current study are not publicly available due to the hospital's confidentiality regulations regarding trial data but are available from the corresponding author on reasonable request.
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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.
Xi Zeng study chair
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine swallowing rehabilitation and real repetitive transcranial magnetic stimulation in people with Stroke and Deglutition Disorders, run by Ruyao Liu at 1 site in China.
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 8 inclusion and 10 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: finished, as of the sponsor's last update on 24 Jan 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Standardized Swallowing Assessment (time frame: day 1 and day 14). 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 24 Jan 2024.