fMRINCT04810234
Neural Correlates of tVNS
An observational study of fMRI and Transcutaneous Vagal Nerve Stimulation (tVNS), run by Maastricht University Medical Center at 2 sites in 2 countries.
Trial summary
Transcutaneous vagal nerve stimulation (tVNS) has been applied to a number of disease areas including visceral pain, depression, cluster headache and Alzheimer's disease. However, there is marked heterogeneity in these studies pertaining to i) the anatomical site of stimulation (neck, inner concha or tragus of ear)… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- fMRI, Transcutaneous Vagal Nerve Stimulation (tVNS), Nucleus of the Solitary Tract (NTS)
- What is being tested?
- transcutaneous vagal nerve stimulation (tVNS)
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Nov 2020to 1 Jun 2021
- Phase
- Observational
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female healthy volunteers aged between 18-40 years
Who may be able to join
- Of female sex;
- Healthy participants (defined as those without a pre-existing medical comorbidity)
- Age between 18 and 40 years;
- BMI between 18 and 30 kg/m2;
- Women on oral contraceptives only
- All subjects should be right-handed.
- Inclusion will be determined on the basis of availability. Subjects should be able to attend for 2 scanning sessions.
Who cannot join
- Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, an intrauterine device, metal braces, tattoos and/or other metal objects;
- History of major head trauma or head/brain surgery;
- History of claustrophobia;
- History of severe or chronic cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, haematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol;
- Use of regular medication, including vitamin and iron supplementation, except oral contraceptives, within 14 days prior to start of the study;
- Pregnancy, lactation, wish to become pregnant;
Show all 18Show fewer
- High alcohol consumption (>15 alcoholic units consumed per week);
- Using drugs of abuse;
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study;
- Participants unable to provide informed consent
- Participants with any systemic disease or medications that may influence the autonomic nervous system (e.g. beta-agonists or Parkinson's disease)
- Current smokers or current use of nicotine in any other way (including E-cigarettes and patches)
- History of clinical anxiety or depression, or a hospital anxiety or depression score >8
- Participants whom score 8 or more on the HADS-questionnaire at study commencement
- Patient whom have cardiovascular conduction problems
- Patient with cochlear implants
- Not meeting any of the inclusion criteria above
- Any evidence of structural brain abnormalities examined by anatomical MRI will lead to exclusion
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, 6229 ER
A.B. Beckers, MD, 0433881844, ab.beckers@maastrichtuniversity.nl
A.A.M. Masclee, Prof. MD. PhD
United Kingdom1 site
- Active, not recruiting
Queen Mary University of London. Wingate Institute of Neurogastroenterology
London
About this study
Official title: Functional Neural Correlates of Transcutaneous Vagal Nerve Stimulation: Effects of Anatomical Site and Waveform Parameters - An Exploratory High Resolution fMRI Study in Healthy Volunteers
Transcutaneous vagal nerve stimulation (tVNS) has been applied to a number of disease areas including visceral pain, depression, cluster headache and Alzheimer's disease. However, there is marked heterogeneity in these studies pertaining to i) the anatomical site of stimulation (neck, inner concha or tragus of ear), and ii) the waveform parameters of the stimulating impulse. This exploratory cross-sectional study will address these knowledge gaps by comparative functional neuroimaging of the neural correlates of tVNS with disparate anatomical sites and electrical waveform characteristics during rest in healthy participants.
- Being tested
- transcutaneous vagal nerve stimulation (tVNS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous vagal nerve stimulation (tVNS)Device
Cervical and auricular transcutaneous stimulation of the vagus nerve
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygenation level dependent (BOLD) signal activity in the CAN during tVNS
fMRI related outcome measure
Measured: During stimulation (difference between stim on - stim off blocks)
Secondary outcomes (6)
Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during auricular tVNS (parameter set 1)
fMRI related outcome measure
Measured: During stimulation (difference between stim on - stim off blocks)
Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during cervical tVNS )(parameter set 1)
fMRI related outcome measure
Measured: During stimulation (difference between stim on - stim off blocks)
Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during auricular tVNS (parameter set 2)
fMRI related outcome measure
Measured: During stimulation (difference between stim on - stim off blocks)
Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during cervical tVNS (parameter set 2)
fMRI related outcome measure
Measured: During stimulation (difference between stim on - stim off blocks)
Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during subliminal auricular tVNS (parameter set 1)
fMRI related outcome measure
Measured: During stimulation (difference between stim on - stim off blocks)
Functional connectivity / Network Connectivity of CAN regions during "active tVNS" block [to all 5 points as identified above]
fMRI related outcome measure
Measured: During stimulation (difference between stim on - stim off blocks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Nov 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for fMRIStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wingate Institute of Neurogastroenterology
- Responsible party
- Sponsor
- Investigators
- Ad Masclee, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810234
- Sponsor's protocol ID
- 65751.068.2018
- Other IDs
- METC183019
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Neural Correlates of Transcutaneous Vagal Nerve Stimulation: Effects of Anatomical Site and Waveform Parameters - An Exploratory High Resolution fMRI Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04810234
- Acronym / sponsor ID
- 65751.068.2018
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Wingate Institute of Neurogastroenterology
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 22 Mar 2021 (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.
Transcutaneous vagal nerve stimulation (tVNS) has been applied to a number of disease areas including visceral pain, depression, cluster headache and Alzheimer's disease. However, there is marked heterogeneity in these studies pertaining to i) the anatomical site of stimulation (neck, inner concha or tragus of ear), and ii) the waveform parameters of the stimulating impulse. This exploratory cross-sectional study will address these knowledge gaps by comparative functional neuroimaging of the neural correlates of tVNS with disparate anatomical sites and electrical waveform characteristics during rest in healthy participants.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female healthy volunteers aged between 18-40 years
Key inclusion criteria (7 listed)
- Of female sex;
- Healthy participants (defined as those without a pre-existing medical comorbidity)
- Age between 18 and 40 years;
- BMI between 18 and 30 kg/m2;
- Women on oral contraceptives only
Key exclusion criteria (18 listed)
- Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, an intrauterine device, metal braces, tattoos and/or other metal objects;
- History of major head trauma or head/brain surgery;
- History of claustrophobia;
- History of severe or chronic cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, haematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol;
- Use of regular medication, including vitamin and iron supplementation, except oral contraceptives, within 14 days prior to start of 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 |
|---|---|---|
| transcutaneous vagal nerve stimulation (tVNS)Cervical and auricular transcutaneous stimulation of the vagus nerve | Device | – |
Primary outcome
Blood oxygenation level dependent (BOLD) signal activity in the CAN during tVNS
Time frame: During stimulation (difference between stim on - stim off blocks)
fMRI related outcome measure
6 secondary outcomes
Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during auricular tVNS (parameter set 1)
Time frame: During stimulation (difference between stim on - stim off blocks)
Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during cervical tVNS )(parameter set 1)
Time frame: During stimulation (difference between stim on - stim off blocks)
Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during auricular tVNS (parameter set 2)
Time frame: During stimulation (difference between stim on - stim off blocks)
Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during cervical tVNS (parameter set 2)
Time frame: During stimulation (difference between stim on - stim off blocks)
Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during subliminal auricular tVNS (parameter set 1)
Time frame: During stimulation (difference between stim on - stim off blocks)
Functional connectivity / Network Connectivity of CAN regions during "active tVNS" block [to all 5 points as identified above]
Time frame: During stimulation (difference between stim on - stim off blocks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
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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.
Ad Masclee, MD, PhD principal investigator
Maastricht University Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of fMRI and Transcutaneous Vagal Nerve Stimulation (tVNS), run by Maastricht University Medical Center at 2 sites in 2 countries.
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 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, United Kingdom. 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 Abraham Beckers, MD (+31433881844, ab.beckers@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood oxygenation level dependent (BOLD) signal activity in the CAN during tVNS (time frame: During stimulation (difference between stim on - stim off blocks)). 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 22 Mar 2021.