Fibromyalgia SyndromeNCT06616181
TDCS and Tele-rehabilitation Exercise in Fibromyalgia
A study testing Anodal tDCS over M1, Anodal tDCS over DLPFC and Exercise telerehabilitation in people with Fibromyalgia Syndrome, run by University of Valladolid.
Trial summary
This randomized controlled trial aims to analyze the effects of anodal tDCS applied over the primary motor cortex and dorsolateral prefrontal cortex combined with a tele-rehabilitation exercise program in patients with fibromyalgia. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- Anodal tDCS over M1, Anodal tDCS over DLPFC and Exercise telerehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30 and 70 years.
- Medical diagnosis of fibromyalgia.Compliance with the latest diagnostic criteria from the American College of Rheumatology.
- Stable medication for at least 12 weeks prior to the start of the study.
- Ability to use communication technologies, such as smartphones and computers.
- Capacity to participate in an aerobic exercise program.
- Access to the internet.
- Proficiency in oral and written Spanish.
- Signed informed consent
Who cannot join
- Severe psychiatric disorders.
- Uncontrolled cardiovascular, respiratory, metabolic, neurological, rheumatic, or hepatic diseases.
- Concurrent chronic inflammatory or autoimmune disease.
- Contraindications to physical activity.
- Metal implants in the head.
- History of cancer, brain tumor, epileptic episodes, stroke, severe head trauma, or brain surgery.
Show all 10Show fewer
- Pregnancy or lactation.
- Use of carbamazepine in the past 6 months.
- Changes in medication during the study.
- Participation in other non-pharmacological conservative therapies (e.g., hydrotherapy, electrotherapy, manual therapy, exercise, dry needling) during the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Anodal TDCS Applied Over M1 and DLPFC Combined with a Telerehabilitation Exercise Program in Patients with Fibromyalgia: a Randomized Controlled Trial
This randomized controlled trial aims to analyze the effects of anodal tDCS applied over the primary motor cortex and dorsolateral prefrontal cortex combined with a tele-rehabilitation exercise program in patients with fibromyalgia. The study will compare these effects with each other and with placebo tDCS on the following variables: pain intensity, pain mechanosensitivity, quality of life, fatigue, anxiety, depression, sleep quality, pain catastrophizing, functional capacity, isometric strength, and exercise adherence.
Secondary objectives include:
Read more
- Describing the sociodemographic, clinical, and functional characteristics of fibromyalgia patients.
- Comparing exercise intensity levels between patients receiving tDCS on M1, DLPFC, and placebo stimulation.
- Reporting any adverse effects of the intervention. Adult participants with fibromyalgia will be randomized into three groups: a) anodal tDCS over M1 + telerehabilitation, b) anodal tDCS over DLPFC + telerehabilitation, and c) sham-tDCS + telerehabilitation. The intervention will last for 12 weeks. The telerehabilitation exercise program will include an aerobic phase and a resistance phase, with four intensity levels regulated based on the Borg Rating of Perceived Exertion (0-10). The program will be conducted remotely through phone contact, with materials and videos provided to guide exercise execution. tDCS will be applied once per week for 20 minutes at 2 mA, either over M1 or DLPFC.
The dependent variables-pain intensity, fibromyalgia impact, fatigue, anxiety and depression levels, pain catastrophizing, sleep quality, functional capacity, and isometric muscle strength-will be collected in the week prior to the intervention, the week following the intervention, and 12 weeks after its completion. Additionally, pain intensity, fibromyalgia impact, fatigue severity, anxiety and depression levels, pain catastrophizing, and sleep quality will be evaluated during the 6th week of the intervention.
Exercise intensity, exercise adherence, and any adverse effects related to the intervention will be recorded weekly.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Anodal tDCS over M1, Anodal tDCS over DLPFC, Exercise telerehabilitation
- Keywords
- tDCS, exercise, telerehabilitation, home-based exercise, fibromyalgia
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCS over M1Device
The anode will be placed over the left M1 (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.
Anodal tDCS over DLPFCDevice
The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC) (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.
Exercise telerehabilitationBehavioural
Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance training will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS over M1 + telerehabilitation | Experimental | tDCS over M1: The anode will be placed over the left M1 (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.
Telerehabilitation Exercise: Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance exercise will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact. Receives: Device: Anodal tDCS over M1; Behavioral: Exercise telerehabilitation |
| Anodal tDCS over DLPFC + telerehabilitation | Experimental | tDCS over DLPFC: The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC) (F3), and the cathode will be positioned over the contralateral supraorbital area (F8). Once the electrodes are positioned, active tDCS will be applied at 2mA for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.
Tele-rehabilitation Exercise: Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance exercise will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact. Receives: Device: Anodal tDCS over DLPFC; Behavioral: Exercise telerehabilitation |
| sham-tDCS + telerehabilitation | Placebo comparator | Sham tDCS: The same electrode placement protocol used for the active tDCS M1 group will be followed in this group. Stimulation will begin with a 30-second ramp-up to reach an intensity of 2 mA, immediately followed by a 30-second ramp-down to 0 mA. This stimulation will be repeated at the beginning and end of the session. Similar to the active tDCS groups, each session will last 20 minutes.
Telerehabilitation Exercise: Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance exercise will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact. Receives: Behavioral: Exercise telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will indicate their pain intensity by placing a perpendicular mark on a 100 mm straight line, where the left end represents \'no pain\'; and the right end represents \'the worst imaginable pain\'. Pain intensity is quantified by measuring the distance in mm from the left end of the line using a ruler.
Measured: At pre-intervention, at weeks 12 and 24.
Secondary outcomes (9)
Pain mechanosensitivity
Pain mechanosensitivity will be assessed by summing the pressure pain thresholds at the 18 tender points described by the ACR in 1990 for the diagnosis of fibromyalgia. The pressure pain threshold is defined as the minimum pressure required to elicit pain. An algometer will be used for measurement. Incremental pressure will be applied at a rate of 1 kg/s at each point until the participant reports the onset of minimal pain. Three measurements will be taken at each point, with a 30-second interval between each. The average of the three measurements will be used to calculate the total sum. The order of measurement for each tender point will be consistent across all participants.
Measured: At pre-intervention, at weeks 12 and 24.
Fatigue
Fatigue will be measured using the Spanish version of the Multidimensional Fatigue Inventory. This scale includes five dimensions: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Each dimension provides a score from 4 to 20, where higher scores indicate greater fatigue.
Measured: At pre-intervention, at weeks 12 and 24.
Sleep Quality
Sleep Quality: Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The minimum score is 0 and the maximum is 21 points, with higher scores indicating poorer sleep quality
Measured: At pre-intervention, at weeks 12 and 24.
Pain Catastrophizing
Pain Catastrophizing: Pain catastrophizing will be assessed using the Spanish version of the Pain Catastrophizing Scale. It has a minimum score of 0 and a maximum score of 52 points, with higher scores indicating greater catastrophizing thoughts about pain.
Measured: At pre-intervention, at weeks 12 and 24.
Isometric Strength
Maximum isometric muscle strength will be measured for elbow flexors and knee extensors by hand-held dynamometry.
Measured: At pre-intervention, at weeks 12 and 24.
Exercise Adherence
Exercise adherence will be estimated as the percentage of completed sessions out of the 24 scheduled sessions. This will be tracked weekly using Google Forms to record the number of sessions completed.
Measured: At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12.
6-Minute Walk Test
In this test, the distance in meters that the participant can walk at a fast but comfortable pace, without running, within 6 minutes will be measured. Two cones will be placed 20 meters apart in an unobstructed hallway.
Measured: At pre-intervention, at 12 and 24 weeks.
30-second Chair Stand Test
This test consists of measuring the number of times the participant can stand up and sit down again in a chair without armrests within 30 seconds.
Measured: At pre-intervention, at weeks 12 and 24.
Fibromyalgia Impact
Fibromyalgia Impact: The impact of fibromyalgia will be measured using the Spanish version of the Revised Fibromyalgia Impact Questionnaire (FIQ-R). The scale ranges from 0 to 100 points, where higher scores indicate a greater impact of fibromyalgia.
Measured: At pre-intervention, at weeks 12 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Hernando Garijo, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616181
- Sponsor's protocol ID
- UValladolid02
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anodal TDCS Applied Over M1 and DLPFC Combined with a Telerehabilitation Exercise Program in Patients with Fibromyalgia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06616181
- Acronym / sponsor ID
- UValladolid02
- Conditions
- Fibromyalgia Syndrome
- Keywords
- tDCS, exercise, telerehabilitation, home-based exercise, fibromyalgia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Sep 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 randomized controlled trial aims to analyze the effects of anodal tDCS applied over the primary motor cortex and dorsolateral prefrontal cortex combined with a tele-rehabilitation exercise program in patients with fibromyalgia. The study will compare these effects with each other and with placebo tDCS on the following variables: pain intensity, pain mechanosensitivity, quality of life, fatigue, anxiety, depression, sleep quality, pain catastrophizing, functional capacity, isometric strength, and exercise adherence.
Secondary objectives include:
- Describing the sociodemographic, clinical, and functional characteristics of fibromyalgia patients.
- Comparing exercise intensity levels between patients receiving tDCS on M1, DLPFC, and placebo stimulation.
- Reporting any adverse effects of the intervention. Adult participants with fibromyalgia will be randomized into three groups: a) anodal tDCS over M1 + telerehabilitation, b) anodal tDCS over DLPFC + telerehabilitation, and c) sham-tDCS + telerehabilitation. The intervention will last for 12 weeks. The telerehabilitation exercise program will include an aerobic phase and a resistance phase, with four intensity levels regulated based on the Borg Rating of Perceived Exertion (0-10). The program will be conducted remotely through phone contact, with materials and videos provided to guide exercise execution. tDCS will be applied once per week for 20 minutes at 2 mA, either over M1 or DLPFC.
The dependent variables-pain intensity, fibromyalgia impact, fatigue, anxiety and depression levels, pain catastrophizing, sleep quality, functional capacity, and isometric muscle strength-will be collected in the week prior to the intervention, the week following the intervention, and 12 weeks after its completion. Additionally, pain intensity, fibromyalgia impact, fatigue severity, anxiety and depression levels, pain catastrophizing, and sleep quality will be evaluated during the 6th week of the intervention.
Exercise intensity, exercise adherence, and any adverse effects related to the intervention will be recorded weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS over M1 + telerehabilitation | Experimental | Device: Anodal tDCS over M1, Behavioral: Exercise telerehabilitationtDCS over M1: The anode will be placed over the left M1 (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks. Telerehabilitation Exercise: Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance exercise will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact. |
| Anodal tDCS over DLPFC + telerehabilitation | Experimental | Device: Anodal tDCS over DLPFC, Behavioral: Exercise telerehabilitationtDCS over DLPFC: The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC) (F3), and the cathode will be positioned over the contralateral supraorbital area (F8). Once the electrodes are positioned, active tDCS will be applied at 2mA for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks. Tele-rehabilitation Exercise: Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance exercise will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact. |
| sham-tDCS + telerehabilitation | Placebo comparator | Behavioral: Exercise telerehabilitationSham tDCS: The same electrode placement protocol used for the active tDCS M1 group will be followed in this group. Stimulation will begin with a 30-second ramp-up to reach an intensity of 2 mA, immediately followed by a 30-second ramp-down to 0 mA. This stimulation will be repeated at the beginning and end of the session. Similar to the active tDCS groups, each session will last 20 minutes. Telerehabilitation Exercise: Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance exercise will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 30 and 70 years.
- Medical diagnosis of fibromyalgia.Compliance with the latest diagnostic criteria from the American College of Rheumatology.
- Stable medication for at least 12 weeks prior to the start of the study.
- Ability to use communication technologies, such as smartphones and computers.
- Capacity to participate in an aerobic exercise program.
Key exclusion criteria (10 listed)
- Severe psychiatric disorders.
- Uncontrolled cardiovascular, respiratory, metabolic, neurological, rheumatic, or hepatic diseases.
- Concurrent chronic inflammatory or autoimmune disease.
- Contraindications to physical activity.
- Metal implants in 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 |
|---|---|---|
| Anodal tDCS over M1The anode will be placed over the left M1 (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks. | Device | Anodal tDCS over M1 + telerehabilitation |
| Anodal tDCS over DLPFCThe anode will be placed over the left dorsolateral prefrontal cortex (DLPFC) (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks. | Device | Anodal tDCS over DLPFC + telerehabilitation |
| Exercise telerehabilitationTwo weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance training will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact. | Behavioural | Anodal tDCS over DLPFC + telerehabilitation, Anodal tDCS over M1 + telerehabilitation, sham-tDCS + telerehabilitation |
Primary outcome
Pain intensity
Time frame: At pre-intervention, at weeks 12 and 24.
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will indicate their pain intensity by placing a perpendicular mark on a 100 mm straight line, where the left end represents \'no pain\'; and the right end represents \'the worst imaginable pain\'. Pain intensity is quantified by measuring the distance in mm from the left end of the line using a ruler.
9 secondary outcomes
Pain mechanosensitivity
Time frame: At pre-intervention, at weeks 12 and 24.
Fatigue
Time frame: At pre-intervention, at weeks 12 and 24.
Sleep Quality
Time frame: At pre-intervention, at weeks 12 and 24.
Pain Catastrophizing
Time frame: At pre-intervention, at weeks 12 and 24.
Isometric Strength
Time frame: At pre-intervention, at weeks 12 and 24.
Exercise Adherence
Time frame: At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12.
6-Minute Walk Test
Time frame: At pre-intervention, at 12 and 24 weeks.
30-second Chair Stand Test
Time frame: At pre-intervention, at weeks 12 and 24.
Fibromyalgia Impact
Time frame: At pre-intervention, at weeks 12 and 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS over M1, Anodal tDCS over DLPFC and Exercise telerehabilitation in people with Fibromyalgia Syndrome, run by University of Valladolid.
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: opening soon, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ignacio Hernando Garijo (975129145, ignacio.hernando@uva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: At pre-intervention, at weeks 12 and 24.). 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 27 Sep 2024.