InflammationOMT_taVNSNCT04177264
Anti-inflammatory Actions of Osteopathic Manipulative Treatment
A study testing Occipito-Atlantal Decompression (OA DC), Splenic Lymphatic Pump Technique (SpLPT) and Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in people with Inflammation, run by Burrell College of Health Sciences at 1 site in United States.
Trial summary
This study evaluates the hypothesis that osteopathic manipulative treatment (OMT) and non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) elicit anti-inflammatory actions through activation of the parasympathetic nervous system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Occipito-Atlantal Decompression (OA DC), Splenic Lymphatic Pump Technique (SpLPT) and Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18 year or above.
Who cannot join
- Age under 18 years
- Pregnancy
- Any findings on the osteopathic screening/evaluation that would hinder the effectiveness - of the occipito-atlantal decompression or splenic lymphatic pump technique
- Any medication that interferes with the autonomic nervous system function or the immune system (e.g., beta-blockers, steroids, TNF-α inhibitors)
- Any medical condition that affects the autonomic nervous system or the immune system (e.g., splenomegaly, Epstein-Barr infection within the last 6 months, autonomic neuropathy, pure autonomic failure, rheumatic or autoimmune diseases, acquired autoimmune deficiency syndrome)
- Any chronic diseases, such as diabetes and hypertension
- Current drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Burrell College of Osteopathic Medicine
Las Cruces, New Mexico, 88001
Harald M Stauss, MD, PhD, 575-674-2327, hstauss@bcomnm.org
About this study
Official title: Anti-inflammatory Actions of OMT - Role of the Cholinergic Anti-inflammatory Pathway and Translocation of Immune Cells From Reticular Organs to the Systemic Circulation
This study evaluates the hypothesis that osteopathic manipulative treatment (OMT) and non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) elicit anti-inflammatory actions through activation of the parasympathetic nervous system. In a cross-over design, research participants will be subjected to various combinations of OMT, taVNS, or sham interventions during four study sessions, that are at least one month apart. During each study session research participants will undergo OMT and/or taVNS for 3 consecutive days. Blood pressure and electrocardiogram (ECG) will be recorded on all three study days to assess parasympathetic nervous system function. On the 3rd study day a blood sample will be taken to assess the effects of OMT and/or taVNS on inflammation.
Read the detailed description
Biological anti-inflammatory drugs, such as TNF-α antagonists, have revolutionized treatment of chronic inflammatory diseases, such as inflammatory bowel disease, rheumatoid arthritis, psoriasis, or other auto-immune disorders and have largely improved prognosis and quality of life of patients affected by these conditions. However, the high cost of these agents is prohibitive for a large number of patients and some patients are not eligible to such treatments because of co-morbidities that constitute contraindications. Thus, there is a need for cost-effective alternative treatment strategies. Activation of the cholinergic anti-inflammatory pathway, which operates through the parasympathetic nervous system, may constitute an alternative approach to treat chronic inflammatory diseases. This pathway has been demonstrated to shift the function of immune cells in reticular organs, such as the spleen from a pro-inflammatory to an anti-inflammatory state. Subsequently, these "reprogrammed" cells translocate to the systemic circulation and reach the site of inflammation. Clinical studies and the investigators' preliminary data suggest that non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) can augment parasympathetic tone and potentially activate the cholinergic anti-inflammatory pathway. Another way of potentially activating this pathway is through osteopathic manipulative treatment (OMT) because some OMT techniques have been demonstrated to increase parasympathetic activity. However, it is not known if such OMT techniques also activate the cholinergic anti-inflammatory pathway. Furthermore, it is not known if osteopathic lymphatic pump techniques augment these anti-inflammatory responses by facilitating translocation of "reprogrammed" immune cells from reticular organs to the systemic circulation. The investigators' long-term goal is to contribute to the development of cost-effective OMT approaches to treat chronic inflammatory diseases. The central hypothesis is that successive applications of different OMT techniques or the combination of taVNS with specific OMT techniques first activate and then augment the cholinergic anti-inflammatory pathway through stimulating parasympathetic tone and facilitating translocation of immune cells. Parasympathetic nervous system function will be assessed by heart rate variability analysis and other cardiovascular parameters that are under the influence of the parasympathetic nervous system. Immune function will be assessed by measuring plasma concentrations of inflammatory mediators (cytokines) and by in vitro cell culture experiments of immune cells. At the completion of these studies, the investigators anticipate to demonstrate that OMT techniques that activate the parasympathetic nervous system and taVNS elicit anti-inflammatory effects. Second, the investigators also anticipate to demonstrate that subsequently applied osteopathic lymphatic pump techniques augment the anti-inflammatory actions of OMT and taVNS by facilitating translocation of "reprogrammed" immune cells from the spleen to the systemic circulation. These outcomes are expected to have important positive impact, because they will potentially lay a mechanistic foundation for future clinical studies applying such combinations of taVNS and OMT techniques to chronic inflammatory diseases, including inflammatory bowel diseases, rheumatoid arthritis, psoriasis, or other auto-immune disorders.
- Conditions
- Inflammation
- Being tested
- Occipito-Atlantal Decompression (OA DC), Sham Occipito-Atlantal Decompression (Sham OA DC), Splenic Lymphatic Pump Technique (SpLPT), Sham Splenic Lymphatic Pump Technique (Sham SpLPT), Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
- Keywords
- osteopathic manipulative treatment, transcutaneous auricular vagus nerve stimulation, cytokines, immune cells, parasympathetic nervous system, heart rate variability
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occipito-Atlantal Decompression (OA DC)Procedure or surgery
The participant lies supine in a relaxed state while the investigator cradles the patient's head with their hands, middle finger pads along the inferior aspect of inion, reaching to the occipito-atlantal joint. The investigator then applies gentle posterior and cephalad traction to the occiput, while bringing the elbows together. This results in supination of the hands and separation of the middle fingers, creating a posterior-lateral force vector to either side of the foramen magnum. The pressure is maintained until softening of the underlying structures is felt. The procedure is applied for 10 minutes.
Sham Occipito-Atlantal Decompression (Sham OA DC)Procedure or surgery
The participant lies supine in a relaxed state while the investigator applies light touch to the patient's head with their hands.
Splenic Lymphatic Pump Technique (SpLPT)Procedure or surgery
With the participant supine, the investigator places a posterior hand along the left lower ribcage, and a superior hand over the left costal arch, encompassing the spleen. The investigatory compresses and releases the spleen at a rate of 20 compressions/min for 3 min.
Sham Splenic Lymphatic Pump Technique (Sham SpLPT)Procedure or surgery
With the participant supine, the investigator places a posterior hand along the left lower ribcage, and a superior hand over the left costal arch, encompassing the spleen. The investigator will maintain light touch at these positions for 3 minutes. No compressions are performed.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Device
A bipolar clip electrode is attached to the auricle at the location of the cymba conchae. Electrical stimulation (30 Hz stimulation frequency, 300 μs pulse width) is applied for 10 min. The stimulation current is determined individually for each participant by slowly increasing the stimulation current until the participants feel a mild tingling sensation at the site of the electrode. Then the current is gradually reduced until the tingling sensation disappears. This current will then be used for taVNS. A TENS 7000 or EMS 7500 device (510(k): K080661) is used.
Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS)Device
A bipolar clip electrode is attached to the auricle at the location of the cymba conchae but no electrical current is applied to the electrode.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT) | Experimental | In 4 randomized study sessions, combinations of two different osteopathic manipulative treatment (OMT) techniques (occipito-atlantal decompression [OA DC] and splenic lymphatic pump technique [SpLPT]) or their respective sham interventions will be performed. The 4 study sessions are at least one month apart and consist of 3 consecutive study days on which the same combination of OMT techniques or sham interventions will be performed. Receives: Procedure: Occipito-Atlantal Decompression (OA DC); Procedure: Sham Occipito-Atlantal Decompression (Sham OA DC); Procedure: Splenic Lymphatic Pump Technique (SpLPT); Procedure: Sham Splenic Lymphatic Pump Technique (Sham SpLPT) |
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) | Experimental | In 4 randomized study sessions, combinations of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), osteopathic splenic lymphatic pump technique (SpLPT) or their respective sham interventions will be performed. The 4 study sessions are at least one month apart and consist of 3 consecutive study days on which the same combination of taVNS, SpLPT, or sham interventions will be performed. Receives: Procedure: Splenic Lymphatic Pump Technique (SpLPT); Procedure: Sham Splenic Lymphatic Pump Technique (Sham SpLPT); Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS) |
| Time Control | No intervention | In 4 study sessions, no intervention will be performed. As with the two experimental arms, the 4 study sessions are at least one month apart and consist of 3 consecutive study days on which no intervention will be performed. This arm serves as a time control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the Interventions on Inflammation
The effect of the interventions on inflammation is assessed by plasma levels of pro- and anti-inflammatory cytokines; activation or inactivation of immune cells in the blood; and release of cytokines from TLR-ligand-activated immune cell cultures. All of these inflammatory measures will be determined from blood samples collected on the third study day and therefore, reflect the cumulative effect of the three study days.
Measured: 2 days
Secondary outcomes (2)
Change in Autonomic Nervous System Function Induced by the Interventions
The change in autonomic nervous system function induced by the interventions is assessed by the difference in heart rate variability parameters and baroreceptor-heart rate reflex sensitivity determined before and after the interventions on each study day.
Measured: 110 minutes
Cumulative Effect of the Interventions on Autonomic Nervous System Function
The cumulative effect of the interventions on autonomic nervous system function is assessed by the change in heart rate variability parameters and baroreceptor-heart rate reflex sensitivity from the first to the third study day.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start6 Jan 2020
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three groups of research participants will undergo four study sessions each, during which different combinations of osteopathic manipulative treatment or sham procedures (OMT, Group 1), transcutaneous auricular vagus nerve stimulation combines with OMT or sham procedures (taVNS, Group 2), or no intervention (Group 3, time control) will be performed.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burrell College of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harald Stauss, Burrell College of Health Sciences
- Investigators
- Harald M Stauss, MD, PhD, Principal investigator, Burrell College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177264
- Sponsor's protocol ID
- BCOM EG 0003_2019
- Acronym
- OMT_taVNS
- Status last verified
- Feb 2023
- First submitted
- 21 Nov 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kania A, Roufail J, Prokop J, Stauss HM. A framework for the interpretation of heart rate variability applied to transcutaneous auricular vagus nerve stimulation and osteopathic manipulation. Physiol Rep. 2024 Mar;12(6):e15981. doi: 10.14814/phy2.15981.
PubMed 38508860
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Actions of OMT - Role of the Cholinergic Anti-inflammatory Pathway and Translocation of Immune Cells From Reticular Organs to the Systemic Circulation
- ClinicalTrials.gov ID
- NCT04177264
- Acronym / sponsor ID
- OMT_taVNS / BCOM EG 0003_2019
- Conditions
- Inflammation
- Keywords
- osteopathic manipulative treatment, transcutaneous auricular vagus nerve stimulation, cytokines, immune cells, parasympathetic nervous system, heart rate variability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Burrell College of Health SciencesUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 26 Nov 2019 (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 study evaluates the hypothesis that osteopathic manipulative treatment (OMT) and non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) elicit anti-inflammatory actions through activation of the parasympathetic nervous system. In a cross-over design, research participants will be subjected to various combinations of OMT, taVNS, or sham interventions during four study sessions, that are at least one month apart. During each study session research participants will undergo OMT and/or taVNS for 3 consecutive days. Blood pressure and electrocardiogram (ECG) will be recorded on all three study days to assess parasympathetic nervous system function. On the 3rd study day a blood sample will be taken to assess the effects of OMT and/or taVNS on inflammation.
Detailed description
Biological anti-inflammatory drugs, such as TNF-α antagonists, have revolutionized treatment of chronic inflammatory diseases, such as inflammatory bowel disease, rheumatoid arthritis, psoriasis, or other auto-immune disorders and have largely improved prognosis and quality of life of patients affected by these conditions. However, the high cost of these agents is prohibitive for a large number of patients and some patients are not eligible to such treatments because of co-morbidities that constitute contraindications. Thus, there is a need for cost-effective alternative treatment strategies. Activation of the cholinergic anti-inflammatory pathway, which operates through the parasympathetic nervous system, may constitute an alternative approach to treat chronic inflammatory diseases. This pathway has been demonstrated to shift the function of immune cells in reticular organs, such as the spleen from a pro-inflammatory to an anti-inflammatory state. Subsequently, these "reprogrammed" cells translocate to the systemic circulation and reach the site of inflammation. Clinical studies and the investigators' preliminary data suggest that non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) can augment parasympathetic tone and potentially activate the cholinergic anti-inflammatory pathway. Another way of potentially activating this pathway is through osteopathic manipulative treatment (OMT) because some OMT techniques have been demonstrated to increase parasympathetic activity. However, it is not known if such OMT techniques also activate the cholinergic anti-inflammatory pathway. Furthermore, it is not known if osteopathic lymphatic pump techniques augment these anti-inflammatory responses by facilitating translocation of "reprogrammed" immune cells from reticular organs to the systemic circulation. The investigators' long-term goal is to contribute to the development of cost-effective OMT approaches to treat chronic inflammatory diseases. The central hypothesis is that successive applications of different OMT techniques or the combination of taVNS with specific OMT techniques first activate and then augment the cholinergic anti-inflammatory pathway through stimulating parasympathetic tone and facilitating translocation of immune cells. Parasympathetic nervous system function will be assessed by heart rate variability analysis and other cardiovascular parameters that are under the influence of the parasympathetic nervous system. Immune function will be assessed by measuring plasma concentrations of inflammatory mediators (cytokines) and by in vitro cell culture experiments of immune cells. At the completion of these studies, the investigators anticipate to demonstrate that OMT techniques that activate the parasympathetic nervous system and taVNS elicit anti-inflammatory effects. Second, the investigators also anticipate to demonstrate that subsequently applied osteopathic lymphatic pump techniques augment the anti-inflammatory actions of OMT and taVNS by facilitating translocation of "reprogrammed" immune cells from the spleen to the systemic circulation. These outcomes are expected to have important positive impact, because they will potentially lay a mechanistic foundation for future clinical studies applying such combinations of taVNS and OMT techniques to chronic inflammatory diseases, including inflammatory bowel diseases, rheumatoid arthritis, psoriasis, or other auto-immune disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three groups of research participants will undergo four study sessions each, during which different combinations of osteopathic manipulative treatment or sham procedures (OMT, Group 1), transcutaneous auricular vagus nerve stimulation combines with OMT or sham procedures (taVNS, Group 2), or no intervention (Group 3, time control) will be performed.
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT) | Experimental | Procedure: Occipito-Atlantal Decompression (OA DC), Procedure: Sham Occipito-Atlantal Decompression (Sham OA DC), Procedure: Splenic Lymphatic Pump Technique (SpLPT), Procedure: Sham Splenic Lymphatic Pump Technique (Sham SpLPT)In 4 randomized study sessions, combinations of two different osteopathic manipulative treatment (OMT) techniques (occipito-atlantal decompression [OA DC] and splenic lymphatic pump technique [SpLPT]) or their respective sham interventions will be performed. The 4 study sessions are at least one month apart and consist of 3 consecutive study days on which the same combination of OMT techniques or sham interventions will be performed. |
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) | Experimental | Procedure: Splenic Lymphatic Pump Technique (SpLPT), Procedure: Sham Splenic Lymphatic Pump Technique (Sham SpLPT), Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS)In 4 randomized study sessions, combinations of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), osteopathic splenic lymphatic pump technique (SpLPT) or their respective sham interventions will be performed. The 4 study sessions are at least one month apart and consist of 3 consecutive study days on which the same combination of taVNS, SpLPT, or sham interventions will be performed. |
| Time Control | No intervention | –In 4 study sessions, no intervention will be performed. As with the two experimental arms, the 4 study sessions are at least one month apart and consist of 3 consecutive study days on which no intervention will be performed. This arm serves as a time control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age of 18 year or above.
Key exclusion criteria (7 listed)
- Age under 18 years
- Pregnancy
- Any findings on the osteopathic screening/evaluation that would hinder the effectiveness - of the occipito-atlantal decompression or splenic lymphatic pump technique
- Any medication that interferes with the autonomic nervous system function or the immune system (e.g., beta-blockers, steroids, TNF-α inhibitors)
- Any medical condition that affects the autonomic nervous system or the immune system (e.g., splenomegaly, Epstein-Barr infection within the last 6 months, autonomic neuropathy, pure autonomic failure, rheumatic or autoimmune diseases, acquired autoimmune deficiency syndrome)
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 |
|---|---|---|
| Occipito-Atlantal Decompression (OA DC)The participant lies supine in a relaxed state while the investigator cradles the patient's head with their hands, middle finger pads along the inferior aspect of inion, reaching to the occipito-atlantal joint. The investigator then applies gentle posterior and cephalad traction to the occiput, while bringing the elbows together. This results in supination of the hands and separation of the middle fingers, creating a posterior-lateral force vector to either side of the foramen magnum. The pressure is maintained until softening of the underlying structures is felt. The procedure is applied for 10 minutes. | Procedure or surgery | Osteopathic Manipulative Treatment (OMT) |
| Sham Occipito-Atlantal Decompression (Sham OA DC)The participant lies supine in a relaxed state while the investigator applies light touch to the patient's head with their hands. | Procedure or surgery | Osteopathic Manipulative Treatment (OMT) |
| Splenic Lymphatic Pump Technique (SpLPT)With the participant supine, the investigator places a posterior hand along the left lower ribcage, and a superior hand over the left costal arch, encompassing the spleen. The investigatory compresses and releases the spleen at a rate of 20 compressions/min for 3 min. | Procedure or surgery | Osteopathic Manipulative Treatment (OMT), Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) |
| Sham Splenic Lymphatic Pump Technique (Sham SpLPT)With the participant supine, the investigator places a posterior hand along the left lower ribcage, and a superior hand over the left costal arch, encompassing the spleen. The investigator will maintain light touch at these positions for 3 minutes. No compressions are performed. | Procedure or surgery | Osteopathic Manipulative Treatment (OMT), Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) |
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)A bipolar clip electrode is attached to the auricle at the location of the cymba conchae. Electrical stimulation (30 Hz stimulation frequency, 300 μs pulse width) is applied for 10 min. The stimulation current is determined individually for each participant by slowly increasing the stimulation current until the participants feel a mild tingling sensation at the site of the electrode. Then the current is gradually reduced until the tingling sensation disappears. This current will then be used for taVNS. A TENS 7000 or EMS 7500 device (510(k): K080661) is used. | Device | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) |
| Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS)A bipolar clip electrode is attached to the auricle at the location of the cymba conchae but no electrical current is applied to the electrode. | Device | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) |
Primary outcome
Effect of the Interventions on Inflammation
Time frame: 2 days
The effect of the interventions on inflammation is assessed by plasma levels of pro- and anti-inflammatory cytokines; activation or inactivation of immune cells in the blood; and release of cytokines from TLR-ligand-activated immune cell cultures. All of these inflammatory measures will be determined from blood samples collected on the third study day and therefore, reflect the cumulative effect of the three study days.
2 secondary outcomes
Change in Autonomic Nervous System Function Induced by the Interventions
Time frame: 110 minutes
Cumulative Effect of the Interventions on Autonomic Nervous System Function
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 38508860Kania A, Roufail J, Prokop J, Stauss HM. A framework for the interpretation of heart rate variability applied to transcutaneous auricular vagus nerve stimulation and osteopathic manipulation. Physiol Rep. 2024 Mar;12(6):e15981. doi: 10.14814/phy2.15981.
- 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.
Harald M Stauss, MD, PhD principal investigator
Burrell College of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occipito-Atlantal Decompression (OA DC), Splenic Lymphatic Pump Technique (SpLPT) and Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in people with Inflammation, run by Burrell College of Health Sciences 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 1 inclusion and 7 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 8 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 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. 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 Harald M Stauss, MD, PhD (575-674-2327, hstauss@bcomnm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the Interventions on Inflammation (time frame: 2 days). 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 NCT04177264, which also lists 1 linked publication.
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 8 Feb 2023.