Long COVIDPhase 2MANIFESTNCT06940609
Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation
A Phase 2 study testing accelerated intermittent theta burst stimulation in people with Long COVID and Long COVID Syndrome, run by University of New Mexico at 1 site in United States.
Trial summary
The goal of this clinical trial is to test whether a type of rapid outpatient brain stimulation that uses magnetic fields, called accelerated intermittent theta burst stimulation (iTBS), can treat symptoms such as brain fog, depression, and anxiety in patients with Long COVID. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Long COVID, Long COVID Syndrome, Long COVID-19 Syndrome
- What is being tested?
- accelerated intermittent theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 30 Jun 2029
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-80
- a documented diagnosis of PASC with evidence of ongoing symptoms as demonstrated by score of 12 on the NIH RECOVER Symptom List
- have "brain fog" or cognitive difficulties as one of the ongoing symptoms
- are fluent in English
- if taking psychotropic medications, have been on stable doses for the past month.
Who cannot join
- a prior history of other neurological disease, or any history of seizures, so as to reduce risk of exacerbation of epilepsy or other neurological symptoms;
- history of a psychotic disorder, such as schizophrenia or bipolar disorder, so as to reduce risk of psychiatric decompensation
- history of ongoing substance/alcohol dependence, to reduce confounding effects on diagnosis and brain imaging
- presence of any implanted electrical device (e.g., pacemaker), to reduce risk of device malfunction from rTMS
- recent medical hospitalization (within four weeks), to reduce risk of medical decompensation during the study
- any condition that would prevent the subject from completing the protocol
Show all 10Show fewer
- appointment of a legal representative, to avoid coercion of a vulnerable population
- any ongoing litigation related to medical diagnosis, or disability, to prevent interference with legal proceedings
- any contraindication to MRI
- membership in an identified vulnerable population, including minors, pregnant women, and prisoners, so as to prevent coercion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of New Mexico Health Science Center
Albuquerque, New Mexico, 87106
Crystal Garcia, 505-272-9552, crabaca@salud.unm.edu
Davin Quinn, MD
About this study
Official title: Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation (MANIFEST)
The goal of this clinical trial is to test whether a type of rapid outpatient brain stimulation that uses magnetic fields, called accelerated intermittent theta burst stimulation (iTBS), can treat symptoms such as brain fog, depression, and anxiety in patients with Long COVID. The main questions it aims to answer are:
- Is iTBS effective and feasible for reducing Long COVID symptoms? We will measure these symptoms using the Symptom Burden Questionnaire.
- Are there changes in inflammatory brain chemicals associated with treatment with iTBS? We will be looking at levels of choline in the brain, which is thought to be related to inflammation.
Read more
Researchers will compare sham versus active forms of iTBS to see if the active group has greater improvement in symptoms.
Participants will complete symptom surveys, cognitive tests, and magnetic resonance imaging scans at the beginning, middle, and end of treatment.
Read the detailed description
Chronic neuropsychiatric symptoms of post-acute sequelae of COVID-19 (neuro-PASC) can lead to disability, loss of function, and reduced quality of life, but there are currently no validated effective treatments. We propose a randomized sham-controlled trial of "Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation (MANIFEST)." We will deliver active or sham accelerated iTBS (5x/day, 10 days, 25 blinded sessions followed by 25 open-label sessions) to each participant's brain target. We will assess neuro-PASC symptoms, mood, anxiety, cognition, and quality of life from baseline to end-of-treatment. We will correlate symptom improvement with clinical and imaging variables.
- Conditions
- Long COVID, Long COVID Syndrome, Long COVID-19 Syndrome, PASC, PASC Post Acute Sequelae of COVID 19
- Being tested
- accelerated intermittent theta burst stimulation
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accelerated intermittent theta burst stimulationDevice
Intermittent theta burst stimulation (iTBS), a FDA-approved form of noninvasive neuromodulation, can reduce neuropsychiatric symptoms and modulate inflammation in the thalamus as detected using dMRS, suggesting a potentially effective and efficient treatment approach with a pathophysiological component that is readily quantifiable.
| Study group | Role | What they receive |
|---|---|---|
| Sham accelerated iTBS | Sham comparator | Sham stimulation is delivered using the same coil as active stimulation, producing an equivalent sound, however it is shielded so that no effective magnetic field reaches the participant's brain. To blind participants to active versus sham condition, a mild electrical skin stimulation that has no brain effects is delivered simultaneously with iTBS at the scalp to both active and sham groups, creating the same sense of skin sensation in both groups. Receives: Device: accelerated intermittent theta burst stimulation |
| Active accelerated iTBS | Experimental | Participants will be assigned to receive fMRI-guided iTBS (5 days, 5 sessions/day) to the left dorsolateral prefrontal cortex (dlPFC) during the sham-controlled phase. Each participant is invited to undergo 25 more sessions (5 more days) of open label, unblinded active accelerated fMRI-guided iTBS to the left dlPFC. Receives: Device: accelerated intermittent theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1
Demonstrate that accelerated iTBS is effective and feasible for reducing neuro-PASC symptoms. Change in the score in the "Cognitive Function/Brain Fog Symptoms" score from the PACS: Post-acute COVID-19 Syndrome Questionnaire, where low scores are more severe symptoms compared to higher scores. Scale 1-Severly Unable to 4-Able. Higher scores show improvement in symptoms.
Measured: From baseline to end of treatment at 2 weeks
Aim 2
Identify neurometabolic and structural features associated with outcomes in MANIFEST. ADCcho in the thalamus measured using dMRS. The apparent diffusion coefficient of choline (ADCcho) is a measure of activity of microglia, higher values indicate higher levels of microglia. Decreased ADCcho means less microglia activation, and less inflammation.
Measured: From baseline to end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start7 Jul 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (64)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- The Mind Research Network, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Davin Quinn, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940609
- Sponsor's protocol ID
- 24-470
- Other IDs
- HT9425-24-1-0742
- Acronym
- MANIFEST
- Status last verified
- Jul 2026
- First submitted
- 2 Apr 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Demographics, symptoms, cognitive testing, and imaging data.
Publications
Genovese G, Marjanska M, Auerbach EJ, Cherif LY, Ronen I, Lehericy S, Branzoli F. In vivo diffusion-weighted MRS using semi-LASER in the human brain at 3 T: Methodological aspects and clinical feasibility. NMR Biomed. 2021 May;34(5):e4206. doi: 10.1002/nbm.4206. Epub 2020 Jan 13.
PubMed 31930768Schubert J, Tonietto M, Turkheimer F, Zanotti-Fregonara P, Veronese M. Supervised clustering for TSPO PET imaging. Eur J Nucl Med Mol Imaging. 2021 Dec;49(1):257-268. doi: 10.1007/s00259-021-05309-z. Epub 2021 Mar 29.
PubMed 33779770Ling JM, Klimaj S, Toulouse T, Mayer AR. A prospective study of gray matter abnormalities in mild traumatic brain injury. Neurology. 2013 Dec 10;81(24):2121-7. doi: 10.1212/01.wnl.0000437302.36064.b1. Epub 2013 Nov 20.
PubMed 24259552Mayer AR, Hanlon FM, Dodd AB, Ling JM, Klimaj SD, Meier TB. A functional magnetic resonance imaging study of cognitive control and neurosensory deficits in mild traumatic brain injury. Hum Brain Mapp. 2015 Nov;36(11):4394-406. doi: 10.1002/hbm.22930. Epub 2015 Aug 19.
PubMed 26493161Mayer AR, Yang Z, Yeo RA, Pena A, Ling JM, Mannell MV, Stippler M, Mojtahed K. A functional MRI study of multimodal selective attention following mild traumatic brain injury. Brain Imaging Behav. 2012 Jun;6(2):343-54. doi: 10.1007/s11682-012-9178-z.
PubMed 22673802Mayer AR, Toulouse T, Klimaj S, Ling JM, Pena A, Bellgowan PS. Investigating the properties of the hemodynamic response function after mild traumatic brain injury. J Neurotrauma. 2014 Jan 15;31(2):189-97. doi: 10.1089/neu.2013.3069. Epub 2013 Nov 20.
PubMed 23965000Davenport ND, Lim KO, Armstrong MT, Sponheim SR. Diffuse and spatially variable white matter disruptions are associated with blast-related mild traumatic brain injury. Neuroimage. 2012 Feb 1;59(3):2017-24. doi: 10.1016/j.neuroimage.2011.10.050. Epub 2011 Oct 20.
PubMed 22040736Davenport ND, Lamberty GJ, Nelson NW, Lim KO, Armstrong MT, Sponheim SR. PTSD confounds detection of compromised cerebral white matter integrity in military veterans reporting a history of mild traumatic brain injury. Brain Inj. 2016;30(12):1491-1500. doi: 10.1080/02699052.2016.1219057.
PubMed 27834537Meier TB, Bellgowan PS, Singh R, Kuplicki R, Polanski DW, Mayer AR. Recovery of cerebral blood flow following sports-related concussion. JAMA Neurol. 2015 May;72(5):530-8. doi: 10.1001/jamaneurol.2014.4778.
PubMed 25730545Mayer AR, Stephenson DD, Wertz CJ, Dodd AB, Shaff NA, Ling JM, Park G, Oglesbee SJ, Wasserott BC, Meier TB, Witkiewitz K, Campbell RA, Yeo RA, Phillips JP, Quinn DK, Pottenger A. Proactive inhibition deficits with normal perfusion after pediatric mild traumatic brain injury. Hum Brain Mapp. 2019 Dec 15;40(18):5370-5381. doi: 10.1002/hbm.24778. Epub 2019 Aug 28.
PubMed 31456319Katz I, Barry CN, Cooper SA, Kasprow WJ, Hoff RA. Use of the Columbia-Suicide Severity Rating Scale (C-SSRS) in a large sample of Veterans receiving mental health services in the Veterans Health Administration. Suicide Life Threat Behav. 2020 Feb;50(1):111-121. doi: 10.1111/sltb.12584. Epub 2019 Aug 23.
PubMed 31441952Hays RD, Spritzer KL, Schalet BD, Cella D. PROMIS(R)-29 v2.0 profile physical and mental health summary scores. Qual Life Res. 2018 Jul;27(7):1885-1891. doi: 10.1007/s11136-018-1842-3. Epub 2018 Mar 22.
PubMed 29569016Davis HE, Assaf GS, McCorkell L, Wei H, Low RJ, Re'em Y, Redfield S, Austin JP, Akrami A. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine. 2021 Aug;38:101019. doi: 10.1016/j.eclinm.2021.101019. Epub 2021 Jul 15.
PubMed 34308300Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation (MANIFEST)
- ClinicalTrials.gov ID
- NCT06940609
- Acronym / sponsor ID
- MANIFEST / 24-470
- Conditions
- Long COVID, Long COVID Syndrome, Long COVID-19 Syndrome, PASC, PASC Post Acute Sequelae of COVID 19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- The Mind Research Network, United States Department of Defense
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 23 Apr 2025 (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 goal of this clinical trial is to test whether a type of rapid outpatient brain stimulation that uses magnetic fields, called accelerated intermittent theta burst stimulation (iTBS), can treat symptoms such as brain fog, depression, and anxiety in patients with Long COVID. The main questions it aims to answer are:
- Is iTBS effective and feasible for reducing Long COVID symptoms? We will measure these symptoms using the Symptom Burden Questionnaire.
- Are there changes in inflammatory brain chemicals associated with treatment with iTBS? We will be looking at levels of choline in the brain, which is thought to be related to inflammation.
Researchers will compare sham versus active forms of iTBS to see if the active group has greater improvement in symptoms.
Participants will complete symptom surveys, cognitive tests, and magnetic resonance imaging scans at the beginning, middle, and end of treatment.
Detailed description
Chronic neuropsychiatric symptoms of post-acute sequelae of COVID-19 (neuro-PASC) can lead to disability, loss of function, and reduced quality of life, but there are currently no validated effective treatments. We propose a randomized sham-controlled trial of "Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation (MANIFEST)." We will deliver active or sham accelerated iTBS (5x/day, 10 days, 25 blinded sessions followed by 25 open-label sessions) to each participant's brain target. We will assess neuro-PASC symptoms, mood, anxiety, cognition, and quality of life from baseline to end-of-treatment. We will correlate symptom improvement with clinical and imaging variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham accelerated iTBS | Sham comparator | Device: accelerated intermittent theta burst stimulationSham stimulation is delivered using the same coil as active stimulation, producing an equivalent sound, however it is shielded so that no effective magnetic field reaches the participant's brain. To blind participants to active versus sham condition, a mild electrical skin stimulation that has no brain effects is delivered simultaneously with iTBS at the scalp to both active and sham groups, creating the same sense of skin sensation in both groups. |
| Active accelerated iTBS | Experimental | Device: accelerated intermittent theta burst stimulationParticipants will be assigned to receive fMRI-guided iTBS (5 days, 5 sessions/day) to the left dorsolateral prefrontal cortex (dlPFC) during the sham-controlled phase. Each participant is invited to undergo 25 more sessions (5 more days) of open label, unblinded active accelerated fMRI-guided iTBS to the left dlPFC. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18-80
- a documented diagnosis of PASC with evidence of ongoing symptoms as demonstrated by score of 12 on the NIH RECOVER Symptom List
- have "brain fog" or cognitive difficulties as one of the ongoing symptoms
- are fluent in English
- if taking psychotropic medications, have been on stable doses for the past month.
Key exclusion criteria (10 listed)
- a prior history of other neurological disease, or any history of seizures, so as to reduce risk of exacerbation of epilepsy or other neurological symptoms;
- history of a psychotic disorder, such as schizophrenia or bipolar disorder, so as to reduce risk of psychiatric decompensation
- history of ongoing substance/alcohol dependence, to reduce confounding effects on diagnosis and brain imaging
- presence of any implanted electrical device (e.g., pacemaker), to reduce risk of device malfunction from rTMS
- recent medical hospitalization (within four weeks), to reduce risk of medical decompensation during the study
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 |
|---|---|---|
| accelerated intermittent theta burst stimulationIntermittent theta burst stimulation (iTBS), a FDA-approved form of noninvasive neuromodulation, can reduce neuropsychiatric symptoms and modulate inflammation in the thalamus as detected using dMRS, suggesting a potentially effective and efficient treatment approach with a pathophysiological component that is readily quantifiable. | Device | Active accelerated iTBS, Sham accelerated iTBS |
Primary outcome
Aim 1
Time frame: From baseline to end of treatment at 2 weeks
Demonstrate that accelerated iTBS is effective and feasible for reducing neuro-PASC symptoms. Change in the score in the "Cognitive Function/Brain Fog Symptoms" score from the PACS: Post-acute COVID-19 Syndrome Questionnaire, where low scores are more severe symptoms compared to higher scores. Scale 1-Severly Unable to 4-Able. Higher scores show improvement in symptoms.
Aim 2
Time frame: From baseline to end of treatment at 2 weeks
Identify neurometabolic and structural features associated with outcomes in MANIFEST. ADCcho in the thalamus measured using dMRS. The apparent diffusion coefficient of choline (ADCcho) is a measure of activity of microglia, higher values indicate higher levels of microglia. Decreased ADCcho means less microglia activation, and less inflammation.
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 15 Jul 2026.
- Background: PubMed 31930768Genovese G, Marjanska M, Auerbach EJ, Cherif LY, Ronen I, Lehericy S, Branzoli F. In vivo diffusion-weighted MRS using semi-LASER in the human brain at 3 T: Methodological aspects and clinical feasibility. NMR Biomed. 2021 May;34(5):e4206. doi: 10.1002/nbm.4206. Epub 2020 Jan 13.
- Background: PubMed 33779770Schubert J, Tonietto M, Turkheimer F, Zanotti-Fregonara P, Veronese M. Supervised clustering for TSPO PET imaging. Eur J Nucl Med Mol Imaging. 2021 Dec;49(1):257-268. doi: 10.1007/s00259-021-05309-z. Epub 2021 Mar 29.
- Background: PubMed 24259552Ling JM, Klimaj S, Toulouse T, Mayer AR. A prospective study of gray matter abnormalities in mild traumatic brain injury. Neurology. 2013 Dec 10;81(24):2121-7. doi: 10.1212/01.wnl.0000437302.36064.b1. Epub 2013 Nov 20.
- Background: PubMed 26493161Mayer AR, Hanlon FM, Dodd AB, Ling JM, Klimaj SD, Meier TB. A functional magnetic resonance imaging study of cognitive control and neurosensory deficits in mild traumatic brain injury. Hum Brain Mapp. 2015 Nov;36(11):4394-406. doi: 10.1002/hbm.22930. Epub 2015 Aug 19.
- Background: PubMed 22673802Mayer AR, Yang Z, Yeo RA, Pena A, Ling JM, Mannell MV, Stippler M, Mojtahed K. A functional MRI study of multimodal selective attention following mild traumatic brain injury. Brain Imaging Behav. 2012 Jun;6(2):343-54. doi: 10.1007/s11682-012-9178-z.
- Background: PubMed 23965000Mayer AR, Toulouse T, Klimaj S, Ling JM, Pena A, Bellgowan PS. Investigating the properties of the hemodynamic response function after mild traumatic brain injury. J Neurotrauma. 2014 Jan 15;31(2):189-97. doi: 10.1089/neu.2013.3069. Epub 2013 Nov 20.
- Background: PubMed 22040736Davenport ND, Lim KO, Armstrong MT, Sponheim SR. Diffuse and spatially variable white matter disruptions are associated with blast-related mild traumatic brain injury. Neuroimage. 2012 Feb 1;59(3):2017-24. doi: 10.1016/j.neuroimage.2011.10.050. Epub 2011 Oct 20.
- Background: PubMed 27834537Davenport ND, Lamberty GJ, Nelson NW, Lim KO, Armstrong MT, Sponheim SR. PTSD confounds detection of compromised cerebral white matter integrity in military veterans reporting a history of mild traumatic brain injury. Brain Inj. 2016;30(12):1491-1500. doi: 10.1080/02699052.2016.1219057.
- Background: PubMed 25730545Meier TB, Bellgowan PS, Singh R, Kuplicki R, Polanski DW, Mayer AR. Recovery of cerebral blood flow following sports-related concussion. JAMA Neurol. 2015 May;72(5):530-8. doi: 10.1001/jamaneurol.2014.4778.
- Background: PubMed 31456319Mayer AR, Stephenson DD, Wertz CJ, Dodd AB, Shaff NA, Ling JM, Park G, Oglesbee SJ, Wasserott BC, Meier TB, Witkiewitz K, Campbell RA, Yeo RA, Phillips JP, Quinn DK, Pottenger A. Proactive inhibition deficits with normal perfusion after pediatric mild traumatic brain injury. Hum Brain Mapp. 2019 Dec 15;40(18):5370-5381. doi: 10.1002/hbm.24778. Epub 2019 Aug 28.
- Background: PubMed 31441952Katz I, Barry CN, Cooper SA, Kasprow WJ, Hoff RA. Use of the Columbia-Suicide Severity Rating Scale (C-SSRS) in a large sample of Veterans receiving mental health services in the Veterans Health Administration. Suicide Life Threat Behav. 2020 Feb;50(1):111-121. doi: 10.1111/sltb.12584. Epub 2019 Aug 23.
- Background: PubMed 29569016Hays RD, Spritzer KL, Schalet BD, Cella D. PROMIS(R)-29 v2.0 profile physical and mental health summary scores. Qual Life Res. 2018 Jul;27(7):1885-1891. doi: 10.1007/s11136-018-1842-3. Epub 2018 Mar 22.
- Individual participant dataSharing planned: Yes. Demographics, symptoms, cognitive testing, and imaging data.
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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.
Davin Quinn, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing accelerated intermittent theta burst stimulation in people with Long COVID and Long COVID Syndrome, run by University of New Mexico at 1 site in United States.
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 5 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: looking for participants now, as of the sponsor's last update on 15 Jul 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Crystal Garcia (505-272-9552, crabaca@salud.unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1 (time frame: From baseline to end of treatment at 2 weeks). 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 NCT06940609, which also lists 64 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 15 Jul 2026.