Ischemic Stroke, AcuteNCT06726941
Effect of Exercise Gene Expression and Histone Modifications in Patients With Hemiplegia
A study testing Physiotherapy and Rehabilitation Practices in people with Ischemic Stroke, Acute and Acute Hemiparesis, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to demonstrate the effect of routine exercise program on neuroplasticity through histone acetylation and gene expression changes in acute stroke survivors from an epigenetic perspective and to investigate the correlation of epigenetic effects with its effects on motor function and quality of… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Ischemic Stroke, Acute, Acute Hemiparesis
- What is being tested?
- Physiotherapy and Rehabilitation Practices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2024to 9 Sep 2026
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who applied to Afyonkarahisar Health Sciences University Physical Therapy and Rehabilitation Clinic for rehabilitation purposes and had a stroke for the first time
- Participants with ischemia as the etiology of stroke
- Participants between the ages of 25-70
- Drugs that have been used for at least 1 month and up to 6 months after a cerebrovascular accident
Who cannot join
- Participants whose stroke etiology is other than ischemia
- Participants with clinically significant neurological disease other than stroke
- Participants with systemic and musculoskeletal diseases that will not tolerate neurological rehabilitation and prevent them from participating
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University
Afyonkarahisar, 0300
About this study
Official title: Effect of Exercise on Neuroplasticity-Related Gene Expression and Histone Modifications in Patients With Hemiplegia
The aim of this study is to demonstrate the effect of routine exercise program on neuroplasticity through histone acetylation and gene expression changes in acute stroke survivors from an epigenetic perspective and to investigate the correlation of epigenetic effects with its effects on motor function and quality of life.
Read the detailed description
Stroke is one of the leading causes of disability worldwide. Hemiplegia is the name of the clinical condition that occurs after a stroke. It is the loss of strength in the arm, leg and sometimes the face on one side of the body. Rehabilitation is vital to minimize the sequelae after a stroke, and patients who undergo continuous professional and systematic rehabilitation after the acute phase tend to recover rapidly. An important therapeutic goal of motor recovery is to maximize neuronal plasticity and facilitate motor tasks through motor learning during therapeutic exercise in the neurorehabilitation of patients with motor dysfunction. In particular, intact motor-related regions of the brain are expected to compensate for the impaired neuronal systems. Therefore, therapeutic exercise is expected to compensate for the impaired neuronal system by altering the (cortical) neuronal network as well as the expression of postsynaptic receptors, presynaptic neurotransmitters, regeneration, modulation and synaptic formation at cortical synapses. Epigenetic mechanisms regulate gene transcription based on modifications of DNA promoter regions and histones in chromatin. Epigenetic mechanisms include various DNA and histone modifications (i.e., methylation and acetylation of DNA and histones). In particular, the acetylation level of specific lysine residues in histones is one of the most powerful epigenetic modifications and is essential for transcriptional regulation. Studies show that exercise reduces the expression and activity of HDACs and increases histone acetylation, upregulating the expression of genes important for neuroplasticity.
Some genes associated with neuroplasticity are:Brain-Derived Neurotrophic Factor (BDNF) , Cyclic adenosine monophasphate Response Element-Binding Protein (CREB1), Growth Associated Protein 43 (GAP43), Neurotrophic Receptor Tyrosine Kinase 2 (NTRK2), Synapsin I (SYN1).
Histone H3 Lysine 27 Acetylation (H3K27ac) plays a critical role in the epigenetic regulation of gene expression and is associated with processes such as neuroplasticity, memory, and learning. Various studies have shown that environmental factors such as exercise can increase H3K27ac levels and thus support neuroplasticity.
In this study, participants with acute hemiplegia will be given the same routine rehabilitation program. Neuroplasticity-related gene expression and histone acetylation levels will be compared in venous blood taken from the patient before and after exercise.
In addition, the patient will be examined before and after exercise, and routine Mini-Mental Test, Brunnstrom, Fulg-Meyer upper and lower extremity evaluation, Spasticity evaluation with modified ashworth scale, Functional Independence Scale, ABILHAND Stroke Hand Function Questionnaire, Stroke Impact Questionnaire, 10-meter walking test will be performed to evaluate quality of life and motor function.
- Conditions
- Ischemic Stroke, Acute, Acute Hemiparesis
- Being tested
- Physiotherapy and Rehabilitation Practices
- Keywords
- ischemic stroke, acute hemiplegia, epigenetics
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy and Rehabilitation PracticesOther
It was planned to give the participants a routine stroke rehabilitation program consisting of 45 minutes of active, passive range of motion exercises and strengthening exercises, balance exercises, walking training and 20 minutes of bicycle ergometry, accompanied by a physiotherapist with at least 5 years of experience in stroke rehabilitation. It was planned to give passive bicycle ergometry to patients without voluntary muscle movement and muscle strength, and active bicycle ergometry to participants with voluntary muscle movement and muscle strength, with the bicycle rehabilitation. It was planned to apply the exercise program to the patients for 5 days a week and for a total of 30 sessions. It will be recommended that they continue the medical treatment they are using during the treatment program. Routine evaluations will be made by the physiatrist before the rehabilitation program starts and 2 tubes of venous blood will be taken from the patients by an experienced nurse
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | This group consists of post-stroke hemiplegia participants who will be included in a physiotherapy and rehabilitation program to evaluate the effects on neuroplasticity-related gene expression and histone modification levels, spasticity levels, motor functions, daily living activities, and quality of life. Receives: Other: Physiotherapy and Rehabilitation Practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic analyses
Real-Time Polymerase Chain Reaction (PCR) method will be used to determine the expression of BDNF, CREB1, GAP43, NTRK2 and SYN1 genes from the peripheral venous blood samples of the participants. The region of interest will be amplified in the Real-Time PCR device using primer pairs specific to the relevant genes. Changes in gene expressions in patients before and after treatment will be determined.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Histone Proteins
Leukocytes will be isolated from blood samples before and after exercise. Isolation of histone proteins will be performed from the isolated leukocytes using the relevant isolation procedures. Pre- and post-treatment levels will be compared.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Histone Acetylation Analysis
H3K27ac levels in the isolated histone proteins will be determined colorimetrically based on the ELISA method. Pre- and post-treatment levels will be compared.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Secondary outcomes (7)
Neurophysiological Assessment
Brunnstrom Staging is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of hemiplegic patients is defined as 6 stages. According to this staging, the lowest stage is stage 1 (flaccid, no voluntary movement stage), and the highest stage is stage 6 (isolated joint movement stage). In Brunnstrom staging, the hand, upper extremity and lower extremity are evaluated separately.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Spasticity Assessment
Spasticity was planned to be evaluated with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 5 points. 0 indicates no increase in muscle tone, and 4 indicates that the extremity is rigid in the flexion and extension directions.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Functional independence scale (FIM)
It is a widely applied, validated and reliable approach to functional assessment in Turkish society. FIM analyzes two different aspects of disability, namely motor and cognitive functions. FIM is a scale consisting of 6 subgroups, namely self-care (42 points), sphincter control (14 points), transfer (21 points), movement (14 points), communication (14 points) and social perception (21 points), and evaluates 18 activities. Each activity is evaluated in terms of functional independence using a 7-point scale. Higher scores indicates independence.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Fugl Meyer Upper Extremity Evaluation Questionnaire
The Fugl-Meyer Upper Extremity Motor Evaluation Questionnaire (FMUE Questionnaire) was developed to quantitatively assess sensorimotor recovery after stroke. It was prepared based on Brunnstrom's stages of motor recovery. The FMUE Questionnaire consists of 33 items, each scored from 0 to 2, where 0 = cannot perform, 1 = partially performs, and 2 = fully performs. The total score is 66. A range of data is available for the FMUE Questionnaire for clinically important minimum differences. A change of 4 to 7 points in chronic stroke and 9 to 10 points in subacute stroke is considered clinically significant.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
A Rasch-built measure of manual ability(ABILHAND) Stroke Hand Function Questionnaire
The ABILHAND Hand Questionnaire was developed in 1998 to measure patient-perceived hand dexterity. It contains 23 questions regarding the patient's difficulty in performing activities. One of the following options is marked: impossible (0 points), difficult (1 point), easy (2 points). The total score is 46.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Stroke Impact Questionnaire
Stroke Impact Scale (SIS) is a stroke-specific health status measure. It consists of 59 items and 8 sections. The patient is asked to evaluate the difficulty experienced in completing each item in the last week on a five-point Likert scale. One point indicates that the patient could not complete the item, and five points indicate that he/she had no difficulty in completing it. It also includes a visual analog scale (0: No improvement, 100: Full recovery) regarding the general perception of recovery after stroke. A Turkish validity and reliability study has been conducted.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
10 meter walk test
The 10 Meter Walk Test is a performance measure used to assess walking or walking speed in meters per second over a short distance. It can be used to determine functional mobility, gait and vestibular function. Participants are asked to walk at maximal speed for 14 m. Marks are placed on the floor for a 2 m acceleration and a 2 m deceleration, a starting point and an ending point. Measurement is started at 2 m. Measurement is finished at 12 m. The time taken for the walk is measured manually using an electronic timer for all participants. The total time for the 10 meter walk is recorded. The 10 m is then divided by the total time (in seconds) taken to complete it. The total time is recorded in m/s. Shorter time duration means better mobility.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start20 Dec 2024
- Primary completion9 Sep 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic Stroke, AcuteStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants enrolled will receive the same treatment. Gene analysis, histone acetylation levels, motor function and quality of life changes will be assessed.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Toktaş, Afyonkarahisar Health Sciences University
- Investigators
- Hasan Toktas, Professor, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726941
- Sponsor's protocol ID
- BBBEPIGENETIC
- Status last verified
- Oct 2026
- First submitted
- 5 Dec 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xing Y, Bai Y. A Review of Exercise-Induced Neuroplasticity in Ischemic Stroke: Pathology and Mechanisms. Mol Neurobiol. 2020 Oct;57(10):4218-4231. doi: 10.1007/s12035-020-02021-1. Epub 2020 Jul 20.
PubMed 32691303Maejima H, Kitahara M, Takamatsu Y, Mani H, Inoue T. Effects of exercise and pharmacological inhibition of histone deacetylases (HDACs) on epigenetic regulations and gene expressions crucial for neuronal plasticity in the motor cortex. Brain Res. 2021 Jan 15;1751:147191. doi: 10.1016/j.brainres.2020.147191. Epub 2020 Nov 2.
PubMed 33152341Penna LG, Pinheiro JP, Ramalho SHR, Ribeiro CF. Effects of aerobic physical exercise on neuroplasticity after stroke: systematic review. Arq Neuropsiquiatr. 2021 Sep;79(9):832-843. doi: 10.1590/0004-282X-ANP-2020-0551.
PubMed 34669820
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on Neuroplasticity-Related Gene Expression and Histone Modifications in Patients With Hemiplegia
- ClinicalTrials.gov ID
- NCT06726941
- Acronym / sponsor ID
- BBBEPIGENETIC
- Conditions
- Ischemic Stroke, Acute, Acute Hemiparesis
- Keywords
- ischemic stroke, acute hemiplegia, epigenetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 10 Dec 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.
The aim of this study is to demonstrate the effect of routine exercise program on neuroplasticity through histone acetylation and gene expression changes in acute stroke survivors from an epigenetic perspective and to investigate the correlation of epigenetic effects with its effects on motor function and quality of life.
Detailed description
Stroke is one of the leading causes of disability worldwide. Hemiplegia is the name of the clinical condition that occurs after a stroke. It is the loss of strength in the arm, leg and sometimes the face on one side of the body. Rehabilitation is vital to minimize the sequelae after a stroke, and patients who undergo continuous professional and systematic rehabilitation after the acute phase tend to recover rapidly. An important therapeutic goal of motor recovery is to maximize neuronal plasticity and facilitate motor tasks through motor learning during therapeutic exercise in the neurorehabilitation of patients with motor dysfunction. In particular, intact motor-related regions of the brain are expected to compensate for the impaired neuronal systems. Therefore, therapeutic exercise is expected to compensate for the impaired neuronal system by altering the (cortical) neuronal network as well as the expression of postsynaptic receptors, presynaptic neurotransmitters, regeneration, modulation and synaptic formation at cortical synapses. Epigenetic mechanisms regulate gene transcription based on modifications of DNA promoter regions and histones in chromatin. Epigenetic mechanisms include various DNA and histone modifications (i.e., methylation and acetylation of DNA and histones). In particular, the acetylation level of specific lysine residues in histones is one of the most powerful epigenetic modifications and is essential for transcriptional regulation. Studies show that exercise reduces the expression and activity of HDACs and increases histone acetylation, upregulating the expression of genes important for neuroplasticity.
Some genes associated with neuroplasticity are:Brain-Derived Neurotrophic Factor (BDNF) , Cyclic adenosine monophasphate Response Element-Binding Protein (CREB1), Growth Associated Protein 43 (GAP43), Neurotrophic Receptor Tyrosine Kinase 2 (NTRK2), Synapsin I (SYN1).
Histone H3 Lysine 27 Acetylation (H3K27ac) plays a critical role in the epigenetic regulation of gene expression and is associated with processes such as neuroplasticity, memory, and learning. Various studies have shown that environmental factors such as exercise can increase H3K27ac levels and thus support neuroplasticity.
In this study, participants with acute hemiplegia will be given the same routine rehabilitation program. Neuroplasticity-related gene expression and histone acetylation levels will be compared in venous blood taken from the patient before and after exercise.
In addition, the patient will be examined before and after exercise, and routine Mini-Mental Test, Brunnstrom, Fulg-Meyer upper and lower extremity evaluation, Spasticity evaluation with modified ashworth scale, Functional Independence Scale, ABILHAND Stroke Hand Function Questionnaire, Stroke Impact Questionnaire, 10-meter walking test will be performed to evaluate quality of life and motor function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants enrolled will receive the same treatment. Gene analysis, histone acetylation levels, motor function and quality of life changes will be assessed.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Physiotherapy and Rehabilitation PracticesThis group consists of post-stroke hemiplegia participants who will be included in a physiotherapy and rehabilitation program to evaluate the effects on neuroplasticity-related gene expression and histone modification levels, spasticity levels, motor functions, daily living activities, and quality of life. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who applied to Afyonkarahisar Health Sciences University Physical Therapy and Rehabilitation Clinic for rehabilitation purposes and had a stroke for the first time
- Participants with ischemia as the etiology of stroke
- Participants between the ages of 25-70
- Drugs that have been used for at least 1 month and up to 6 months after a cerebrovascular accident
Key exclusion criteria (3 listed)
- Participants whose stroke etiology is other than ischemia
- Participants with clinically significant neurological disease other than stroke
- Participants with systemic and musculoskeletal diseases that will not tolerate neurological rehabilitation and prevent them from participating
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 |
|---|---|---|
| Physiotherapy and Rehabilitation PracticesIt was planned to give the participants a routine stroke rehabilitation program consisting of 45 minutes of active, passive range of motion exercises and strengthening exercises, balance exercises, walking training and 20 minutes of bicycle ergometry, accompanied by a physiotherapist with at least 5 years of experience in stroke rehabilitation. It was planned to give passive bicycle ergometry to patients without voluntary muscle movement and muscle strength, and active bicycle ergometry to participants with voluntary muscle movement and muscle strength, with the bicycle rehabilitation. It was planned to apply the exercise program to the patients for 5 days a week and for a total of 30 sessions. It will be recommended that they continue the medical treatment they are using during the treatment program. Routine evaluations will be made by the physiatrist before the rehabilitation program starts and 2 tubes of venous blood will be taken from the patients by an experienced nurse | Other | Experimental Group |
Primary outcome
Genetic analyses
Time frame: Baseline (pre-treatment) and 6 weeks (post-treatment)
Real-Time Polymerase Chain Reaction (PCR) method will be used to determine the expression of BDNF, CREB1, GAP43, NTRK2 and SYN1 genes from the peripheral venous blood samples of the participants. The region of interest will be amplified in the Real-Time PCR device using primer pairs specific to the relevant genes. Changes in gene expressions in patients before and after treatment will be determined.
Histone Proteins
Time frame: Baseline (pre-treatment) and 6 weeks (post-treatment)
Leukocytes will be isolated from blood samples before and after exercise. Isolation of histone proteins will be performed from the isolated leukocytes using the relevant isolation procedures. Pre- and post-treatment levels will be compared.
Histone Acetylation Analysis
Time frame: Baseline (pre-treatment) and 6 weeks (post-treatment)
H3K27ac levels in the isolated histone proteins will be determined colorimetrically based on the ELISA method. Pre- and post-treatment levels will be compared.
7 secondary outcomes
Neurophysiological Assessment
Time frame: Baseline (pre-treatment) and 6 weeks (post-treatment)
Spasticity Assessment
Time frame: Baseline (pre-treatment) and 6 weeks (post-treatment)
Functional independence scale (FIM)
Time frame: Baseline (pre-treatment) and 6 weeks (post-treatment)
Fugl Meyer Upper Extremity Evaluation Questionnaire
Time frame: Baseline (pre-treatment) and 6 weeks (post-treatment)
A Rasch-built measure of manual ability(ABILHAND) Stroke Hand Function Questionnaire
Time frame: Baseline (pre-treatment) and 6 weeks (post-treatment)
Stroke Impact Questionnaire
Time frame: Baseline (pre-treatment) and 6 weeks (post-treatment)
10 meter walk test
Time frame: Baseline (pre-treatment) and 6 weeks (post-treatment)
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 7 Oct 2026.
- Background: PubMed 32691303Xing Y, Bai Y. A Review of Exercise-Induced Neuroplasticity in Ischemic Stroke: Pathology and Mechanisms. Mol Neurobiol. 2020 Oct;57(10):4218-4231. doi: 10.1007/s12035-020-02021-1. Epub 2020 Jul 20.
- Background: PubMed 33152341Maejima H, Kitahara M, Takamatsu Y, Mani H, Inoue T. Effects of exercise and pharmacological inhibition of histone deacetylases (HDACs) on epigenetic regulations and gene expressions crucial for neuronal plasticity in the motor cortex. Brain Res. 2021 Jan 15;1751:147191. doi: 10.1016/j.brainres.2020.147191. Epub 2020 Nov 2.
- Background: PubMed 34669820Penna LG, Pinheiro JP, Ramalho SHR, Ribeiro CF. Effects of aerobic physical exercise on neuroplasticity after stroke: systematic review. Arq Neuropsiquiatr. 2021 Sep;79(9):832-843. doi: 10.1590/0004-282X-ANP-2020-0551.
- A Review of Exercise-Induced Neuroplasticity in Ischemic Stroke.Link provided by the sponsor.
- Effects of exercise and pharmacological inhibition of histone deacetylases (HDACs) on epigenetic regulations and gene expressions crucial for neuronal plasticity in the motor cortex.Link provided by the sponsor.
- Effects of aerobic physical exercise on neuroplasticity after stroke.Link provided by the sponsor.
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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.
Hasan Toktas, Professor principal investigator
Afyonkarahisar Health Sciences 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 Physiotherapy and Rehabilitation Practices in people with Ischemic Stroke, Acute and Acute Hemiparesis, 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 4 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: finished, as of the sponsor's last update on 7 Oct 2026. 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. 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?
Genetic analyses (time frame: Baseline (pre-treatment) and 6 weeks (post-treatment)). The study lists 3 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 NCT06726941, which also lists 3 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 7 Oct 2026.