Functional Gastrointestinal DisordersNCT04247100

A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders

A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Functional Gastrointestinal Disorders and Vagus Nerve Autonomic Disorder, run by Gisela Grotewold Chelimsky at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to see if using a micro-current through a device called a TENS (Transcutaneous Electrical Nerve Stimulator) unit helps to improve functional gastrointestinal disorder (FGID) symptoms in children by stimulation of the vagus nerve. Read more about this study

Who is it for?: Ages 12 to 18 years, women only
Conditions the study is for: Functional Gastrointestinal Disorders, Vagus Nerve Autonomic Disorder, Irritable Bowel Syndrome
What is being tested?: Transcutaneous Electrical Nerve Stimulation (TENS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2020to 23 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 to 18 years
Women only
No healthy volunteers
Child, Adult

Who may be able to join

Female patients 12-18 years old with chronic idiopathic nausea, function abdominal pain, dyspepsia and/or irritable bowel syndrome
English Speaking

Who cannot join

Patients who are unable to stand upright during the heart rate variability recording
Patients with a known bleeding disorder
Gastric or cardiac pacer or defibrillator
Poor circulation in lower limbs
Swollen or inflamed outer ear
Epilepsy

Show all 10Show fewer

Abdominal or inguinal hernia
Any unstable medical condition, such as renal disease, uncontrolled diabetes, etc.
Requires new medication during the 8 weeks of the study that may affect gastrointestinal symptoms, vagal modulation or immune response
Inability to answer questionnaires or report pain on a 0-10 visual analog scale.

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Commonwealth University
Richmond, Virginia, 23284

Other trials in United States

About this study

Official title: A Pilot Study of a Randomized Sham-control Auricular TENS Unit Stimulation to Improve Symptoms Through Vagal Modulation in Pediatric Functional Gastrointestinal Disorders

Conditions: Functional Gastrointestinal Disorders, Vagus Nerve Autonomic Disorder, Irritable Bowel Syndrome, Nausea, Dyspepsia
Being tested: Transcutaneous Electrical Nerve Stimulation (TENS), Sham Transcutaneous Electrical Nerve Stimulation
Medical subject headings: Gastrointestinal Diseases, Irritable Bowel Syndrome, Nausea, Dyspepsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcutaneous Electrical Nerve Stimulation (TENS)Device
Also called InTENSity Select Combo by Roscoe Medical
Active Transcutaneous Auricular Microstimulation delivered by TENS device
Sham Transcutaneous Electrical Nerve StimulationDevice
Also called InTENSity Select Combo by Roscoe Medical (Inactive)
Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered

Study groups in NCT04247100
Study group	Role	What they receive
Active Stimulation (8)	Experimental	Participants will receive active auricular microstimulation via TENS unit for 8 weeks. Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS)
Sham Stimulation (4), Active (4)	Sham comparator	Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks. Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS). Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Device: Sham Transcutaneous Electrical Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Heart Rate Variability at 4 Weeks
EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.
Measured: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.
Change in Heart Rate Variability at 8 Weeks
EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.
Measured: Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.
Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 4 Weeks (Basal Consumption)
Blood draw will be tested for mitochondrial function by Seahorse assay, which measures Basal Oxygen Consumption Rate of live cells to provide insight into mitochondrial activity.
Measured: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.
Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 8 Weeks (Basal Consumption)
Blood draw will be tested for mitochondrial function by Seahorse assay, which measures Basal Oxygen Consumption Rate of live cells to provide insight into mitochondrial activity.
Measured: Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.
Change in Blood Cytokines Measured by TNF α Levels at 4 Weeks
Blood will be analyzed to detect changes in protein cytokine TNF α levels, an indicator for inflammation.
Measured: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.
Change in Blood Cytokines Measured by TNF α Levels at 8 Weeks
Blood will be analyzed to detect changes in protein cytokine TNF α levels, an indicator for inflammation
Measured: Assessed at baseline, week 4, and week 8. Change in baseline to week 8.

Secondary outcomes (6)

Change From Baseline in Functional Disability Inventory (Child and Adolescent)
The Functional Disability Inventory (FDI) Child and Adolescent questionnaire will be used to assess change in symptoms. Participants will rank physical trouble or difficulty completing 15 different daily activities (Eating regular meals, Being at school all day, Walking up stairs, etc.) on a scale of 0-4 for each item (0-No trouble, 1- A Little Trouble, 2- Some Trouble, 3- A Lot of Trouble, 4- Impossible). Higher total scores indicate more difficulty functioning due to physical health, based on a sum score of each item. Sum score interpretation cutoffs include: No/Minimal Disability (0-12), Mild Disability (13-20), Moderate Disability (21-29) and Severe Disability (≥30).
Measured: Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported.
Change From Baseline in Symptom Intensity Questionnaire
Symptom Intensity Questionnaire score will be used to identify the most prominent 5 complaints, with intensity rated on a 10-point centimeter Likert scale. Participants write up to 5 of their most severe symptoms, and then rate those symptoms' severity from none (0) to worst you can possibly imagine (10) by placing a vertical line on the scale. Higher symptom ratings reflect higher symptom intensity \& frequency. A 1-3 frequency level is a minimum level and indicates symptoms are occasional. A 4-6 frequency is a moderate level, meaning that symptoms are intermittent, coming and going. A 7-8 frequency is an indication that the symptoms are present more often than not but still not constant. A 9-10 frequency level is severe and indicates that symptoms are constant. The electronic data capture system's field validation used during the study automatically translated the participant-facing 0-10 slider scale placement into a score of 0-100, hence the reported mean values of over 10.
Measured: Assessed at baseline, week 4, and week 8. Changes per symptom score in baseline to week 4 and baseline to week 8 are reported.
Change From Baseline in Pain Catastrophizing Scale (Child)
The Pain Catastrophizing Scale Child form (PCS-C) will be completed by the participant. The PCS-C is a modification of the adult Pain Catastrophizing Scale for use in children, measuring pain-related cognitions and the dimensions of helplessness, rumination and magnification. Participants rate how strong their feelings are about pain on a 5 point scale (0- Not at all, 1- To a slight degree, 2- To a moderate degree, 3- To a great degree, 4- All the time). Sum scores range from 0-52. Higher scores indicate higher levels of pain catastrophizing. A total PCS score of 30 represents a clinically relevant level of catastrophizing.
Measured: Assessed at baseline, week 4, and week 8. Score change in baseline to week 8 is reported.
Change From Baseline in Revised Child Anxiety and Depression Scale
The Revised Child Anxiety and Depression Scale (RCADS) assesses children grades 3 to 12 containing subscales assessing for symptoms of anxiety and depression. Participants rate frequency of occurrences described in the items on a 4 point scale (0- Never, 1- Sometimes, 2- Often, or 3- Always). Sum scores of anxiety/depression items were assessed.
Depression items: score range 0-30 Anxiety items: score range 0-18
Higher scores on both the depression \& anxiety items indicate higher levels of depression \& anxiety.
Raw sum scores of both the depression \& anxiety subscale items are translated to a T-score.
T-scores below 65 represent low severity. T-scores between 65-70 represent medium severity and are on the borderline clinical threshold.
T-scores above 70 represent high severity and are above the clinical threshold. A T-score of 50 indicates the population mean with a standard deviation of 10.
Measured: Assessed at baseline, week 4, and week 8. Changes in generalized anxiety & depression t-scores (translated from raw subscale scores) in baseline to week 4 and baseline to week 8 are reported.
Change From Baseline in Functional Disability Inventory (Parent)
The Functional Disability Inventory (FDI) Parent questionnaire will be used to assess change in the participants symptoms as rated by the participants parent/guardian. Parents will rank their child's physical trouble or difficulty completing 15 different daily activities (Eating regular meals, Being at school all day, Walking up stairs, etc.) on a scale of 0-4 for each item (0-No trouble, 1- A Little Trouble, 2- Some Trouble, 3- A Lot of Trouble, 4- Impossible). Higher total scores indicate more difficulty functioning due to physical health, based on a sum score of each item. Sum score interpretation cutoffs include: No/Minimal Disability (0-12), Mild Disability (13-20), Moderate Disability (21-29) and Severe Disability (≥30).
Measured: Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported.
Change From Baseline in Pain Catastrophizing Scale (Parent)
The Pain Catastrophizing Scale Parent form (PCS-P) will be completed by the parent or guardian of the participant. The PCS-P is a proxy questionnaire to the PCS-C, measuring the feelings the parent has when their child is in pain. Parents rate how strongly they feel when their child is in pain on a 5 point scale (0- Not at all, 1- To a slight degree, 2- To a moderate degree, 3- To a great degree, 4- All the time). Sum scores range from 0-52. Higher scores indicate higher levels of pain catastrophizing. A total PCS score of 30 represents a clinically relevant level of catastrophizing.
Measured: Assessed at baseline, week 4, and week 8. Score change from baseline to week 8 is reported.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202023 Aug 2021

First posted29 Jan 2020
Study start1 Sep 2020
Primary completion23 Aug 2021
Study completion23 Aug 2021

Why it stopped: Funding ended prior to hitting the enrollment goal

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Functional Gastrointestinal DisordersStudies 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
Model description: 30 participants will be enrolled in this double-blind sham control study. Fifteen participants will undergo sham stimulation for 4 weeks followed by active microstimulation for 4 weeks. The other 15 participants will have active microstimulation for all 8 weeks.
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04247100
Sponsor's protocol ID: HM20026558
Status last verified: Oct 2023
First submitted: 22 Jan 2020
Last updated: 12 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18.
PubMed 28826627
Brock C, Brock B, Aziz Q, Moller HJ, Pfeiffer Jensen M, Drewes AM, Farmer AD. Transcutaneous cervical vagal nerve stimulation modulates cardiac vagal tone and tumor necrosis factor-alpha. Neurogastroenterol Motil. 2017 May;29(5). doi: 10.1111/nmo.12999. Epub 2016 Dec 12.
PubMed 27957782
Ji RR, Xu ZZ, Gao YJ. Emerging targets in neuroinflammation-driven chronic pain. Nat Rev Drug Discov. 2014 Jul;13(7):533-48. doi: 10.1038/nrd4334. Epub 2014 Jun 20.
PubMed 24948120

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of a Randomized Sham-control Auricular TENS Unit Stimulation to Improve Symptoms Through Vagal Modulation in Pediatric Functional Gastrointestinal Disorders
ClinicalTrials.gov ID: NCT04247100
Acronym / sponsor ID: HM20026558
Conditions: Functional Gastrointestinal Disorders, Vagus Nerve Autonomic Disorder, Irritable Bowel Syndrome, Nausea, Dyspepsia
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funding ended prior to hitting the enrollment goal
Enrolment: 10 participants (actual)
Lead sponsor: Gisela Grotewold ChelimskyUniversity, hospital or other
Study start: 1 Sep 2020 (actual)
Primary completion: 23 Aug 2021 (actual)
Study completion: 23 Aug 2021 (actual)
First posted: 29 Jan 2020 (actual)
Results: Posted 12 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2
Model description: 30 participants will be enrolled in this double-blind sham control study. Fifteen participants will undergo sham stimulation for 4 weeks followed by active microstimulation for 4 weeks. The other 15 participants will have active microstimulation for all 8 weeks.

Arm	Type	Receives
Active Stimulation (8)	Experimental	Device: Transcutaneous Electrical Nerve Stimulation (TENS)Participants will receive active auricular microstimulation via TENS unit for 8 weeks. Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.
Sham Stimulation (4), Active (4)	Sham comparator	Device: Transcutaneous Electrical Nerve Stimulation (TENS), Device: Sham Transcutaneous Electrical Nerve StimulationParticipants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks. Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).

Who may qualify

Ages: 12 to 18 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

Female patients 12-18 years old with chronic idiopathic nausea, function abdominal pain, dyspepsia and/or irritable bowel syndrome
English Speaking

Key exclusion criteria (10 listed)

Patients who are unable to stand upright during the heart rate variability recording
Patients with a known bleeding disorder
Gastric or cardiac pacer or defibrillator
Poor circulation in lower limbs
Swollen or inflamed outer ear

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 Electrical Nerve Stimulation (TENS)Also: InTENSity Select Combo by Roscoe MedicalActive Transcutaneous Auricular Microstimulation delivered by TENS device	Device	Active Stimulation (8), Sham Stimulation (4), Active (4)
Sham Transcutaneous Electrical Nerve StimulationAlso: InTENSity Select Combo by Roscoe Medical (Inactive)Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered	Device	Sham Stimulation (4), Active (4)

Primary outcome

Change in Heart Rate Variability at 4 Weeks
Time frame: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.
EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.
Change in Heart Rate Variability at 8 Weeks
Time frame: Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.
EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.
Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 4 Weeks (Basal Consumption)
Time frame: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.
Blood draw will be tested for mitochondrial function by Seahorse assay, which measures Basal Oxygen Consumption Rate of live cells to provide insight into mitochondrial activity.
Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 8 Weeks (Basal Consumption)
Time frame: Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.
Blood draw will be tested for mitochondrial function by Seahorse assay, which measures Basal Oxygen Consumption Rate of live cells to provide insight into mitochondrial activity.
Change in Blood Cytokines Measured by TNF α Levels at 4 Weeks
Time frame: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.
Blood will be analyzed to detect changes in protein cytokine TNF α levels, an indicator for inflammation.
Change in Blood Cytokines Measured by TNF α Levels at 8 Weeks
Time frame: Assessed at baseline, week 4, and week 8. Change in baseline to week 8.
Blood will be analyzed to detect changes in protein cytokine TNF α levels, an indicator for inflammation

6 secondary outcomes

Change From Baseline in Functional Disability Inventory (Child and Adolescent)
Time frame: Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported.
Change From Baseline in Symptom Intensity Questionnaire
Time frame: Assessed at baseline, week 4, and week 8. Changes per symptom score in baseline to week 4 and baseline to week 8 are reported.
Change From Baseline in Pain Catastrophizing Scale (Child)
Time frame: Assessed at baseline, week 4, and week 8. Score change in baseline to week 8 is reported.
Change From Baseline in Revised Child Anxiety and Depression Scale
Time frame: Assessed at baseline, week 4, and week 8. Changes in generalized anxiety & depression t-scores (translated from raw subscale scores) in baseline to week 4 and baseline to week 8 are reported.
Change From Baseline in Functional Disability Inventory (Parent)
Time frame: Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported.
Change From Baseline in Pain Catastrophizing Scale (Parent)
Time frame: Assessed at baseline, week 4, and week 8. Score change from baseline to week 8 is reported.

Results and safety

Results posted to the registry on 12 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Stimulation (8)	5	4
Sham Stimulation (4), Active (4)	5	4

Primary outcome: Change in Heart Rate Variability at 4 Weeks

Time frame: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.. Mean (Standard Deviation). Unit: milliseconds (ms)^2

Measure	Active Stimulation (8) n = 4	Sham Stimulation (4), Active (4) n = 4
Standing	-639 (988)	-264 (244)
Supine	5360 (11500)	-5440 (9340)

Primary outcome: Change in Heart Rate Variability at 8 Weeks

Time frame: Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.. Mean (Standard Deviation). Unit: milliseconds (ms)^2

Measure	Active Stimulation (8) n = 4	Sham Stimulation (4), Active (4) n = 4
Standing	-678 (1520)	-65.9 (613)
Supine	1640 (3750)	-8550 (11200)

Primary outcome: Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 4 Weeks (Basal Consumption)

Time frame: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.. Mean (Standard Deviation). Unit: pmol/min/μg of protein

Measure	Active Stimulation (8) n = 4	Sham Stimulation (4), Active (4) n = 4
Value	19.5 (27)	6.47 (26.5)

Primary outcome: Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 8 Weeks (Basal Consumption)

Time frame: Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.. Mean (Standard Deviation). Unit: pmol/min/μg of protein

Measure	Active Stimulation (8) n = 4	Sham Stimulation (4), Active (4) n = 1
Value	35.3 (7.6)	31 (NA)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 2 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Stimulation (8)	0 of 5 (0%)	1 of 5 (20%)	0 of 5
Active Stimulation for 4 Weeks (Following Sham Stimulation)	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Sham Stimulation for 4 Weeks	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28826627Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18.
Background: PubMed 27957782Brock C, Brock B, Aziz Q, Moller HJ, Pfeiffer Jensen M, Drewes AM, Farmer AD. Transcutaneous cervical vagal nerve stimulation modulates cardiac vagal tone and tumor necrosis factor-alpha. Neurogastroenterol Motil. 2017 May;29(5). doi: 10.1111/nmo.12999. Epub 2016 Dec 12.
Background: PubMed 24948120Ji RR, Xu ZZ, Gao YJ. Emerging targets in neuroinflammation-driven chronic pain. Nat Rev Drug Discov. 2014 Jul;13(7):533-48. doi: 10.1038/nrd4334. Epub 2014 Jun 20.
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.

Gisela Chelimsky, MD principal investigator

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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: stopped early, as of the sponsor's last update on 12 Oct 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. 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?

Yes. Results are posted in the registry (first posted 12 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Heart Rate Variability at 4 Weeks (time frame: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.). The study lists 6 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 NCT04247100, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.