Lower Urinary Tract SymptomsNCT05738863
The Effect of Repetative Transcranial Magnetic Stimulation Therapy for Stroke Patients
A study testing Low Frequency rTMS Protocol in people with Lower Urinary Tract Symptoms, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate the effect of repetitive transcranial magnetic stimulation therapy (rTMS) on lower urinary system dysfunctions and detrusor muscle activity in stroke patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Low Frequency rTMS Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2022to 1 Jun 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A person between the ages of 40-80 who applied to AFSU Physical Medicine and Rehabilitation Clinic with the diagnosis of stroke in the inpatient service or outpatient for neurological rehabilitation,
- Having had a stroke at least three months ago,
- Able to follow two-stage verbal commands and agree to participate in the study voluntarily and regularly,
- Medically stable,
- Neurologically stable,
- After taking the anamnesis and physical examination, patients who meet the inclusion criteria and whose exclusion criteria were excluded will be included in the study
Who cannot join
- Patients with significant comorbidities such as severe heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, arrhythmia, pacemaker) and uncontrolled hypertension,
- Epilepsy, history of antiepileptic drug use intracranial metal body,
- Having an ear implant,
- Cognitive dysfunction,
- Lower extremity peripheral nerve injury
- Malignancy
Show all 13Show fewer
- Active infection
- Infection on the skin in the application area, open wound
- İnflammatory disease
- Orthopedic injuries that can limit maximal effort contractions
- Brain lesion or history of drug use that may affect seizure threshold
- İncreased intracranial pressure
- Patients with uncontrolled migraine
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03200
Ayşenur Beysel, MD, 5544808858 ext. +90, aysenur.beysel94@gmail.com
Hilal Yeşil, MD, 5054423141 ext. +90, dradanur@yahoo.com
About this study
Official title: The Effect of Repetative Transcranial Magnetic Stimulation Therapy on Lower Urinary System Dysfunctions in Stroke Patients
The aim of our study is to investigate the effect of repetitive transcranial magnetic stimulation therapy (rTMS) on lower urinary system dysfunctions and detrusor muscle activity in stroke patients.
Read the detailed description
Stroke is the second leading cause of death in adults and one of the major causes of long-term disability. Functional limitations that develop in the post-stroke period affect the quality of life and activities of daily living of the patients. The main purpose of stroke rehabilitation is to improve the quality of life of patients in the areas of physical, functional, psychological and social health.
Post-stroke urinary incontinence (PSUI) is a common complication that manifests as involuntary loss of urine. It has been reported that post-stroke urinary incontinence (PSUI) affects 40-60% of patients admitted to the hospital after stroke, up to 25% still have problems when they are discharged from the hospital, and 15% remain incontinence one year later. Recent studies have shown that 79% of stroke survivors develop urinary incontinence.
It has been reported that this complication is also associated with psychological problems such as low self-esteem and anxiety. In addition, the presence of urinary incontinence has been considered a marker of stroke severity and a higher mortality rate than those without urinary incontinence. Therefore, Post-stroke urinary incontinence (PSUI) management is critical and should be the goal of all stroke health professionals.
In recent years, there is a need for more effective approaches on neuroplasticity mechanisms in stroke rehabilitation. Repetitive transcranial magnetic stimulation (rTMS) is an innovative approach applied in this field. With the application of repetitive transcranial magnetic stimulation (rTMS), it is aimed to modulate plasticity and restore the normal activity pattern.
Repetitive transcranial magnetic stimulation (rTMS) is a painless non-invasive technique widely used in clinical routine practice to modulate the neural excitability of the human brain. High frequency rTMS (>5 Hz) increases neural activity (long term potentiation), while low frequency (1 Hz) rTMS decreases neural activity (long term depression).
Previous studies have shown that detrusor overactivity (DO) constitutes the major urodynamic model of post-stroke urinary incontinence (PSUI).This suggests that the brain, which is the center of incontinence with detrusor overactivity, is a potential target for therapeutic interventions.
Repetitive transcranial magnetic stimulation (rTMS) is a newly developed noninvasive brain stimulation method for the treatment of neurological disorders.When applied to cortical areas corresponding to the pelvic region, it can modulate cortical excitability and induce long-lasting neuroplastic changes.
High-frequency rTMS (>5 Hz) increases neural activity (long-term potentiation), low-frequency (1 Hz) rTMS decreases neural activity. (long-term depression). Clinical studies have shown that inhibition of bladder activity is possible with low frequency (≤ 1 Hz) rTMS in the primary motor cortex (M1).
Our primary aim is to investigate the effect of low-frequency rTMS treatment on urinary system dysfunctions in the primary motor cortex (M1) in stroke patients.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Low Frequency rTMS Protocol, Sham rTMS Protocol
- Keywords
- hemiplegia, urinary dysfunction, detrusor overactivity
- Medical subject headings
- Lower Urinary Tract Symptoms, Hemiplegia, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Frequency rTMS ProtocolDevice
It was planned to apply 1 Hz low-frequency inhibition protocol to the primary motor cortex 5 days a week for 3 weeks, for a total of 15 sessions.
rTMS application Magventure MagPro R30 device is planned to provide magnetic stimulation with its stimulator. The stimulation pattern was shaped according to the protocols used in previous studies.
All patients were planned to continue the neurological rehabilitation program throughout the study.
Along with the daily rTMS session, patients will continue to use the drugs in the medical treatment they are using and the drugs started for incontinence at the same effective dose, and no new incontinence medication will be started and the dose will not be changed during the rTMS sessions.
Sham rTMS ProtocolDevice
It was planned to apply the recorded beat sound to the primary motor cortex area daily 5 days a week for 3 weeks, for a total of 15 sessions by turning the TMS coil with the reverse side and in a 90-angle upright position.
All patients were planned to continue the neurological rehabilitation program throughout the study.
Along with the daily rTMS session, patients will continue to use the drugs in the medical treatment they are using and the drugs started for incontinence at the same effective dose, and no new incontinence medication will be started and the dose will not be changed during the rTMS sessions.
| Study group | Role | What they receive |
|---|---|---|
| Low Frequency rTMS Protocol | Experimental | It was planned to apply 1 Hz low-frequency inhibition protocol to the primary motor cortex 5 days a week for 3 weeks, for a total of 15 sessions. Receives: Device: Low Frequency rTMS Protocol |
| Sham rTMS Protocol | Placebo comparator | It was planned to apply the recorded beat sound to the primary motor cortex area daily 5 days a week for 3 weeks, for a total of 15 sessions by turning the TMS coil with the reverse side and in a 90-angle upright position. Receives: Device: Sham rTMS Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Danish Scale at 15th day and 8th week
The questionnaire consists of 12 questions about lower urinary tract symptoms (LUTS). It is a questionnaire study that questions the frequency and severity of their symptoms (symptom score) and its effect on their daily life (discomfort score) from the participants. It is one of the reliable methods that questions the frequency and severity of lower urinary tract symptoms and disturbing factors.
Measured: up to 8th week
Change from baseline International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at 15th day and 8th week
Evaluates the severity of urinary incontinence symptoms and their impact on health-related quality of life. When using the ICIQ-UI SF, an overall ICIQ score in the range of 0-21 is obtained from the first three questions. A score of zero means no urine leakage and no impact on quality of life. Question 1 (Q1) measures the frequency of urinary incontinence, question 2 (Q2) evaluates the amount of leakage, and question 3 (Q3) evaluates how much urinary incontinence affects daily life.
Measured: up to 8th week
Secondary outcomes (6)
Change from baseline Uroflowmetry and residual urine at 15th day and 8th week
It is one of the ideal follow-up methods due to its ease and non-invasiveness in the evaluation of lower urinary system dysfunction. The maximum flow rate, mean flow rate, voided volume, and the corresponding postvoid residual urine are evaluated.
Measured: up to 8th week
Change from baseline Overactive Bladder Symptom Score (OABSS) at 15th day and 8th week
It includes questions that address the four symptoms of overactive bladder (daytime frequency, nighttime frequency, urgency, urge to incontinence) designed to measure overactive bladder symptoms as a single score. It is a test consisting of questions such as how many times the need to urinate after waking up in the morning before going to sleep, how many times the need to wake up to urinate from sleep to wake up in the morning, how often the urge to urinate is difficult to postpone, and how often urine is leaked because the sudden urge to urinate cannot be delayed.
Measured: up to 8th week
Change from baseline Urinary Incontinence Quality Of Life Scale at 15th day and 8th week
It has been shown to be useful in clinical practice to evaluate the effects of lower urinary system dysfunction on individuals, the discomfort, embarrassment, withdrawal from social life and deterioration in interpersonal relationships on individual lives; It is an assessment consisting of 22 questions that can cover different areas and characterize symptom severity as well as deterioration in lifestyle.
Measured: up to 8th week
Change from baseline Barthel İndex at 15th day and 8th week
It is a measure of independence in activities of daily living. It is a daily life activity index consisting of 10 questions consisting of nutrition, transfer from wheelchair, self-care, sitting on the toilet, bathing, walking on the right floor, using a wheelchair, going up and down stairs, dressing, undressing, bowel care, bladder care.
Measured: up to 8th week
Change from baseline Beck's Depression Inventory at 15th day and 8th week
t is a self-assessment scale that can be used in healthy patient groups to determine the risk of depression in the individual and to measure the level and severity of depressive symptoms. It includes a total of 21 self-assessment questions.
It provides a four-point Likert-type measurement. Each item gets progressively increasing points between 0 and 3, and the total score is obtained by summing them up. The total score ranges from 0 to 63
Measured: up to 8th week
Change from baseline Quality of Life (Short Form 36 (SF-36)) at 15th day and 8th week [
This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score was between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100. Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health.
Measured: up to 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start2 Dec 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Effects of Repetative Transcranial Magnetic Stimulation Therapy on Lower Urinary System Dysfunctions in Stroke Patients; A Randomized Study of Double Blind With Sham Control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşenur Beysel, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738863
- Sponsor's protocol ID
- 586
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang W, Tang W, Song Y, Feng Y, Zhou Y, Li L, Tan B. Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial. Trials. 2022 Aug 13;23(1):650. doi: 10.1186/s13063-022-06535-y.
PubMed 35964135Nardone R, Versace V, Sebastianelli L, Brigo F, Golaszewski S, Christova M, Saltuari L, Trinka E. Transcranial magnetic stimulation and bladder function: A systematic review. Clin Neurophysiol. 2019 Nov;130(11):2032-2037. doi: 10.1016/j.clinph.2019.08.020. Epub 2019 Sep 3.
PubMed 31541980
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Repetative Transcranial Magnetic Stimulation Therapy on Lower Urinary System Dysfunctions in Stroke Patients
- ClinicalTrials.gov ID
- NCT05738863
- Acronym / sponsor ID
- 586
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- hemiplegia, urinary dysfunction, detrusor overactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 22 Feb 2023 (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 our study is to investigate the effect of repetitive transcranial magnetic stimulation therapy (rTMS) on lower urinary system dysfunctions and detrusor muscle activity in stroke patients.
Detailed description
Stroke is the second leading cause of death in adults and one of the major causes of long-term disability. Functional limitations that develop in the post-stroke period affect the quality of life and activities of daily living of the patients. The main purpose of stroke rehabilitation is to improve the quality of life of patients in the areas of physical, functional, psychological and social health.
Post-stroke urinary incontinence (PSUI) is a common complication that manifests as involuntary loss of urine. It has been reported that post-stroke urinary incontinence (PSUI) affects 40-60% of patients admitted to the hospital after stroke, up to 25% still have problems when they are discharged from the hospital, and 15% remain incontinence one year later. Recent studies have shown that 79% of stroke survivors develop urinary incontinence.
It has been reported that this complication is also associated with psychological problems such as low self-esteem and anxiety. In addition, the presence of urinary incontinence has been considered a marker of stroke severity and a higher mortality rate than those without urinary incontinence. Therefore, Post-stroke urinary incontinence (PSUI) management is critical and should be the goal of all stroke health professionals.
In recent years, there is a need for more effective approaches on neuroplasticity mechanisms in stroke rehabilitation. Repetitive transcranial magnetic stimulation (rTMS) is an innovative approach applied in this field. With the application of repetitive transcranial magnetic stimulation (rTMS), it is aimed to modulate plasticity and restore the normal activity pattern.
Repetitive transcranial magnetic stimulation (rTMS) is a painless non-invasive technique widely used in clinical routine practice to modulate the neural excitability of the human brain. High frequency rTMS (>5 Hz) increases neural activity (long term potentiation), while low frequency (1 Hz) rTMS decreases neural activity (long term depression).
Previous studies have shown that detrusor overactivity (DO) constitutes the major urodynamic model of post-stroke urinary incontinence (PSUI).This suggests that the brain, which is the center of incontinence with detrusor overactivity, is a potential target for therapeutic interventions.
Repetitive transcranial magnetic stimulation (rTMS) is a newly developed noninvasive brain stimulation method for the treatment of neurological disorders.When applied to cortical areas corresponding to the pelvic region, it can modulate cortical excitability and induce long-lasting neuroplastic changes.
High-frequency rTMS (>5 Hz) increases neural activity (long-term potentiation), low-frequency (1 Hz) rTMS decreases neural activity. (long-term depression). Clinical studies have shown that inhibition of bladder activity is possible with low frequency (≤ 1 Hz) rTMS in the primary motor cortex (M1).
Our primary aim is to investigate the effect of low-frequency rTMS treatment on urinary system dysfunctions in the primary motor cortex (M1) in stroke patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Effects of Repetative Transcranial Magnetic Stimulation Therapy on Lower Urinary System Dysfunctions in Stroke Patients; A Randomized Study of Double Blind With Sham Control
| Arm | Type | Receives |
|---|---|---|
| Low Frequency rTMS Protocol | Experimental | Device: Low Frequency rTMS ProtocolIt was planned to apply 1 Hz low-frequency inhibition protocol to the primary motor cortex 5 days a week for 3 weeks, for a total of 15 sessions. |
| Sham rTMS Protocol | Placebo comparator | Device: Sham rTMS ProtocolIt was planned to apply the recorded beat sound to the primary motor cortex area daily 5 days a week for 3 weeks, for a total of 15 sessions by turning the TMS coil with the reverse side and in a 90-angle upright position. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A person between the ages of 40-80 who applied to AFSU Physical Medicine and Rehabilitation Clinic with the diagnosis of stroke in the inpatient service or outpatient for neurological rehabilitation,
- Having had a stroke at least three months ago,
- Able to follow two-stage verbal commands and agree to participate in the study voluntarily and regularly,
- Medically stable,
- Neurologically stable,
Key exclusion criteria (13 listed)
- Patients with significant comorbidities such as severe heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, arrhythmia, pacemaker) and uncontrolled hypertension,
- Epilepsy, history of antiepileptic drug use intracranial metal body,
- Having an ear implant,
- Cognitive dysfunction,
- Lower extremity peripheral nerve injury
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 |
|---|---|---|
| Low Frequency rTMS ProtocolIt was planned to apply 1 Hz low-frequency inhibition protocol to the primary motor cortex 5 days a week for 3 weeks, for a total of 15 sessions. rTMS application Magventure MagPro R30 device is planned to provide magnetic stimulation with its stimulator. The stimulation pattern was shaped according to the protocols used in previous studies. All patients were planned to continue the neurological rehabilitation program throughout the study. Along with the daily rTMS session, patients will continue to use the drugs in the medical treatment they are using and the drugs started for incontinence at the same effective dose, and no new incontinence medication will be started and the dose will not be changed during the rTMS sessions. | Device | Low Frequency rTMS Protocol |
| Sham rTMS ProtocolIt was planned to apply the recorded beat sound to the primary motor cortex area daily 5 days a week for 3 weeks, for a total of 15 sessions by turning the TMS coil with the reverse side and in a 90-angle upright position. All patients were planned to continue the neurological rehabilitation program throughout the study. Along with the daily rTMS session, patients will continue to use the drugs in the medical treatment they are using and the drugs started for incontinence at the same effective dose, and no new incontinence medication will be started and the dose will not be changed during the rTMS sessions. | Device | Sham rTMS Protocol |
Primary outcome
Change from baseline Danish Scale at 15th day and 8th week
Time frame: up to 8th week
The questionnaire consists of 12 questions about lower urinary tract symptoms (LUTS). It is a questionnaire study that questions the frequency and severity of their symptoms (symptom score) and its effect on their daily life (discomfort score) from the participants. It is one of the reliable methods that questions the frequency and severity of lower urinary tract symptoms and disturbing factors.
Change from baseline International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at 15th day and 8th week
Time frame: up to 8th week
Evaluates the severity of urinary incontinence symptoms and their impact on health-related quality of life. When using the ICIQ-UI SF, an overall ICIQ score in the range of 0-21 is obtained from the first three questions. A score of zero means no urine leakage and no impact on quality of life. Question 1 (Q1) measures the frequency of urinary incontinence, question 2 (Q2) evaluates the amount of leakage, and question 3 (Q3) evaluates how much urinary incontinence affects daily life.
6 secondary outcomes
Change from baseline Uroflowmetry and residual urine at 15th day and 8th week
Time frame: up to 8th week
Change from baseline Overactive Bladder Symptom Score (OABSS) at 15th day and 8th week
Time frame: up to 8th week
Change from baseline Urinary Incontinence Quality Of Life Scale at 15th day and 8th week
Time frame: up to 8th week
Change from baseline Barthel İndex at 15th day and 8th week
Time frame: up to 8th week
Change from baseline Beck's Depression Inventory at 15th day and 8th week
Time frame: up to 8th week
Change from baseline Quality of Life (Short Form 36 (SF-36)) at 15th day and 8th week [
Time frame: up to 8th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Results publication: PubMed 35964135Jiang W, Tang W, Song Y, Feng Y, Zhou Y, Li L, Tan B. Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial. Trials. 2022 Aug 13;23(1):650. doi: 10.1186/s13063-022-06535-y.
- Results publication: PubMed 31541980Nardone R, Versace V, Sebastianelli L, Brigo F, Golaszewski S, Christova M, Saltuari L, Trinka E. Transcranial magnetic stimulation and bladder function: A systematic review. Clin Neurophysiol. 2019 Nov;130(11):2032-2037. doi: 10.1016/j.clinph.2019.08.020. Epub 2019 Sep 3.
- Individual participant dataSharing planned: No
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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 Low Frequency rTMS Protocol in people with Lower Urinary Tract Symptoms, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
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 6 inclusion and 13 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 22 Feb 2023. 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 Turkey (Türkiye). 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 Ayşenur Beysel, MD (5544808858 ext. +90, aysenur.beysel94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Danish Scale at 15th day and 8th week (time frame: up to 8th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05738863, which also lists 2 linked publications.
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 22 Feb 2023.