Trial Outcomes & Findings for Does Improving Vagal Tone Increase Mitochondrial Bioenergetics (NCT NCT03931330)

Results Overview

Blood draw will be tested for mitochondrial function, including basal respiratory capacity, ATP production and spare respiration and to detect changes in protein which can be an indicator for inflammation. Basal Respiratory Capacity (pmol/min) is better when value is higher.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

Baseline, at follow-up visit 4 (Week 4) and at follow up visit 5 (Week 8 or 12)

Results posted on

2021-06-21

Participant Flow

recruited form the pediatric neurogastrointestinal clinic, from 2/6/2019 to 5/23/2019

Participant milestones

Participant milestones
Measure	Only Active Devise, Open Label active devise, 4 weeks
Overall Study STARTED	8
Overall Study 4 Weeks of Neuromodulation	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Only Active Devise, Open Label active devise, 4 weeks
Overall Study Physician Decision	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Percutaneous Neurostimulation n=7 Participants Subjects will have 4 weeks of active therapy. Percutaneous neurostimulation: Percutaneous neurostimulation using NSS-2 Bridge device
Age, Categorical <=18 years	7 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=7 Participants
Sex: Female, Male Female	7 Participants n=7 Participants
Sex: Female, Male Male	0 Participants n=7 Participants

PRIMARY outcome

Timeframe: Baseline, at follow-up visit 4 (Week 4) and at follow up visit 5 (Week 8 or 12)

Population: Per protocol maximal respiration data was collected for patients at baseline, after completing all 4 weeks of NSS Bridge Neurostim therapy and long term follow up post therapy.

Blood draw will be tested for mitochondrial function, including basal respiratory capacity, ATP production and spare respiration and to detect changes in protein which can be an indicator for inflammation. Basal Respiratory Capacity (pmol/min) is better when value is higher.

Outcome measures

Outcome measures
Measure	Only Active Devise, Open Label n=7 Participants Mitochondrial bioenergetics is decreased in adolescents with FGID, we postulate that a 4 week neuro-stimulation with an EAD that has already shown to increase vagal tone will produce an increase in mitochondrial bioenergetics in this patient group.
To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity Week 1	221.85 pmol/min Standard Deviation 195.35
To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity Week 4	151.14 pmol/min Standard Deviation 101.97
To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory Capacity Week 8	139.20 pmol/min Standard Deviation 120.12

SECONDARY outcome

Timeframe: At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and 5 (Week 8 or 12)

EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.

Outcome measures

Outcome measures
Measure	Only Active Devise, Open Label n=7 Participants Mitochondrial bioenergetics is decreased in adolescents with FGID, we postulate that a 4 week neuro-stimulation with an EAD that has already shown to increase vagal tone will produce an increase in mitochondrial bioenergetics in this patient group.
To Measure Heart Rate Variability Total	97.35 Beats per minute Standard Deviation 18.17
To Measure Heart Rate Variability Week 1	100.31 Beats per minute Standard Deviation 17.31
To Measure Heart Rate Variability Week 4	97.27 Beats per minute Standard Deviation 21.69
To Measure Heart Rate Variability Week 8	93.86 Beats per minute Standard Deviation 15.63

SECONDARY outcome

Timeframe: At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and visit 5 (8 or 12)

The Functional Disability Inventory (FDI) 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. Scale:0-No trouble 1. A little trouble 2. Some Trouble 3. A lot of Trouble 4. Impossible Higher scores (4) indicate more difficulty functioning due to physical health. The total score ranges from 0 to 60 among 15 questions. The individual score for all 15 questions are added together for the total score. If all 15 questions are answered as 0- no trouble then the total score would be 0 (lowest difficulty). If all 15 questions are answered as 4-Impossible, then the total score would be 60 (highest difficulty). An assortment of answers will fall within this 0-60 range depending on the difficulty level answer for each question.

Outcome measures

Outcome measures
Measure	Only Active Devise, Open Label n=7 Participants Mitochondrial bioenergetics is decreased in adolescents with FGID, we postulate that a 4 week neuro-stimulation with an EAD that has already shown to increase vagal tone will produce an increase in mitochondrial bioenergetics in this patient group.
To Measure Functional Disability Inventory Week 1	26.53 score on a scale Standard Deviation 14.04
To Measure Functional Disability Inventory Week 4	24.58 score on a scale Standard Deviation 15.25
To Measure Functional Disability Inventory Week 8	22.70 score on a scale Standard Deviation 17.47
To Measure Functional Disability Inventory Total	24.74 score on a scale Standard Deviation 14.60

Adverse Events

Only Active Device, Open Label

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gisela Chelimsky, MD

Medical College of Wisconsin

Phone: 414-266-3690

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place