Trial Outcomes & Findings for Optimization of Transcutaneous Electrical Acustimulation (TEA) Modalities for Treatment of IBS-C (NCT NCT04953728)

Last Updated: 2024-02-16

Results Overview

The barostat device will measure the pressure changes in the rectum during controlled distension, as measured in mmHg. The study participant's maximum tolerance of distention will be compared to tolerance pre and post TEA, as well as comparing each administration to the other modalities and the sham. Higher numbers represent a higher degree of tolerance. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' pain/discomfort may have changed over time between sessions. Each change value listed below represents the mean of the differences between each participant's tolerance with stimulation and that participant's baseline for that day.

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off.

Results posted on

2024-02-16

Participant Flow

Recruitment was opened in May 2021, and the first participant was consented July 1, 2021. Recruitment closed in September 2022.

Participant milestones

Participant milestones
Measure	Subjects With IBS-C All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 and 3 weeks apart. Transcutaneous Electrical Acustimulation (TEA): Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session.
Overall Study STARTED	23
Overall Study ST36 100 HZ	20
Overall Study ST36 25 HZ	20
Overall Study PC6 100 HZ	20
Overall Study PC6 25 HZ	19
Overall Study Sham 25 HZ	22
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Subjects With IBS-C All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 and 3 weeks apart. Transcutaneous Electrical Acustimulation (TEA): Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session.
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	1

Baseline Characteristics

Only data from participants who were administered all treatments (19 participants) was analyzed to ensure pre- and post-comparisons by individual. Where data is presented for only 18 participants, 1 participant at baseline did not reach a maximum tolerance even at the maximum-offered pressure.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With IBS-C n=23 Participants All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 to 3 weeks apart. Transcutaneous Electrical Acustimulation (TEA): Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session.
Age, Continuous	36.26 years STANDARD_DEVIATION 8.62 • n=23 Participants
Sex: Female, Male Female	20 Participants n=23 Participants
Sex: Female, Male Male	3 Participants n=23 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=23 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=23 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=23 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=23 Participants
Race (NIH/OMB) Asian	1 Participants n=23 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=23 Participants
Race (NIH/OMB) Black or African American	3 Participants n=23 Participants
Race (NIH/OMB) White	17 Participants n=23 Participants
Race (NIH/OMB) More than one race	0 Participants n=23 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=23 Participants
Region of Enrollment United States	23 Participants n=23 Participants
Pressure of Maximum Tolerance Average baseline maximum tolerance of subjects pre ST36 100Hz	47.22 mmHg STANDARD_DEVIATION 9.74 • n=18 Participants • Only data from participants who were administered all treatments (19 participants) was analyzed to ensure pre- and post-comparisons by individual. Where data is presented for only 18 participants, 1 participant at baseline did not reach a maximum tolerance even at the maximum-offered pressure.
Pressure of Maximum Tolerance Average baseline maximum tolerance of subjects pre ST36 25Hz	45.53 mmHg STANDARD_DEVIATION 10.12 • n=19 Participants • Only data from participants who were administered all treatments (19 participants) was analyzed to ensure pre- and post-comparisons by individual. Where data is presented for only 18 participants, 1 participant at baseline did not reach a maximum tolerance even at the maximum-offered pressure.
Pressure of Maximum Tolerance Average baseline maximum tolerance of subjects pre PC6 100Hz	47.22 mmHg STANDARD_DEVIATION 9.27 • n=18 Participants • Only data from participants who were administered all treatments (19 participants) was analyzed to ensure pre- and post-comparisons by individual. Where data is presented for only 18 participants, 1 participant at baseline did not reach a maximum tolerance even at the maximum-offered pressure.
Pressure of Maximum Tolerance Average baseline maximum tolerance of subjects pre PC6 25Hz	49.17 mmHg STANDARD_DEVIATION 10.18 • n=18 Participants • Only data from participants who were administered all treatments (19 participants) was analyzed to ensure pre- and post-comparisons by individual. Where data is presented for only 18 participants, 1 participant at baseline did not reach a maximum tolerance even at the maximum-offered pressure.
Pressure of Maximum Tolerance Average baseline maximum tolerance of subjects pre sham	46.39 mmHg STANDARD_DEVIATION 10.26 • n=18 Participants • Only data from participants who were administered all treatments (19 participants) was analyzed to ensure pre- and post-comparisons by individual. Where data is presented for only 18 participants, 1 participant at baseline did not reach a maximum tolerance even at the maximum-offered pressure.

PRIMARY outcome

Timeframe: Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off.

Population: Data was analyzed only for participants who received all 5 treatments to avoid the compounding impact of day-to-day variations. In the case of PC6 100 HZ, post-treatment value is missing for 1 participant.

Outcome measures

Outcome measures
Measure	Subjects With IBS-C n=19 Participants All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 and 3 weeks apart. Transcutaneous Electrical Acustimulation (TEA): Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session.
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. Change in avg max tolerance per person: value at sham minus value at that day's baseline	1.84 mmHg Standard Error 1.03
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. Change in avg max tolerance per person: value at ST36 100Hz minus value at that day's baseline	0.79 mmHg Standard Error 1.80
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. Change in avg max tolerance per person: value at ST36 25Hz minus value at that day's baseline	1.32 mmHg Standard Error 2.26
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. Change in avg max tolerance per person: value at PC6 100Hz minus value at that day's baseline	-4.44 mmHg Standard Error 2.45
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. Change in avg max tolerance per person: value at PC6 25Hz minus value at that day's baseline	-4.21 mmHg Standard Error 3.40

PRIMARY outcome

Timeframe: After 15 minutes of treatment, rectum was distended incrementally with treatment for up to 12 minutes. Because between sessions, participants had 1-3 weeks off, the maximum time between 1 maximum-tolerated distension and another was 12 weeks.

Population: For each of the rows of data below, data from 19 participants at one treatment are compared with data from either 19 or 18 participants in the other treatment.

The barostat device measured the pressure changes in the rectum during controlled distension, as measured in mmHg. The study participant's maximum tolerance of distention was compared to tolerance pre and post TEA, as well as comparing each administration to the other modalities and the sham for that person. Higher numbers represent a higher degree of tolerance. Scores were compared between modalities of body position (ST36 or PC6), frequency (100 Hz or 25 Hz), and sham. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. Analysis is shown as a difference in treatment-induced change between different treatment modalities rather than a comparison between the average maximums under 1 treatment or another for the group as a whole.

Outcome measures

Outcome measures
Measure	Subjects With IBS-C n=19 Participants All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 and 3 weeks apart. Transcutaneous Electrical Acustimulation (TEA): Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session.
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. Change in avg max tolerance per person: value at ST36 25Hz minus value at sham	-0.53 mmHg Standard Error 1.64
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. Change in avg max tolerance per person: value at ST36 100Hz minus value at ST36 25Hz	-0.53 mmHg Standard Error 2.03
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. Change in avg max tolerance per person: value at ST36 100Hz minus value at PC6 100Hz	-1.66 mmHg Standard Error 1.04
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. Change in avg max tolerance per person: value at ST36 100Hz minus value at PC6 25Hz	5.00 mmHg Standard Error 2.60
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. Change in avg max tolerance per person: value at ST36 100Hz minus value at sham	-1.05 mmHg Standard Error 1.42
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. Change in avg max tolerance per person: value at ST36 25Hz minus value at PC6 100Hz	-1.13 mmHg Standard Error 1.26
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. Change in avg max tolerance per person: value at ST36 25Hz minus value at PC6 25Hz	5.53 mmHg Standard Error 2.83
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. Change in avg max tolerance per person: value at PC6 100Hz minus value at PC6 25Hz	6.66 mmHg Standard Error 1.84
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. Change in avg max tolerance per person: value at PC6 100Hz minus value at sham	0.61 mmHg Standard Error 0.65
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. Change in avg max tolerance per person: value at PC6 25Hz minus value at sham	-6.05 mmHg Standard Error 2.22

SECONDARY outcome

Timeframe: Up to 8 mins between 15 and 50 mmHg during baseline. After deflating balloon, 15 mins of treatment and resumption of distention (up to 30 mins later), more surveys were taken during treatment increasing distensions up to 8 mins between 15 and 50 mmHg.

VAS surveys, a pain scale from 0 (lowest) to 10 (highest), were taken to assess efficacy of treatment on a 10-point scale. The minimum possible score was 0 and the maximum possible score was 80, if a participant experienced 10/10 pain. These scores were collected at 15 through 50 mmHg of distension at 5-mmHg intervals during baseline and compared to the scores collected at the same intervals during treatment on the same day. Data below show values post stimulation minus pre stimulation. Each participant came in for 1 treatment in 1 session on each of 5 separate days. Sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' pain/discomfort may have changed over time between sessions. Analysis is shown as a single arm rather than a cross-over because the averages below are calculated from the change in each participant's pain compared only to their own pain.

Outcome measures

Outcome measures
Measure	Subjects With IBS-C n=19 Participants All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 and 3 weeks apart. Transcutaneous Electrical Acustimulation (TEA): Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session.
Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration. ST36 100Hz	-7.74 score on a scale Standard Error 1.82
Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration. ST36 25Hz	-0.94 score on a scale Standard Error 2.84
Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration. PC6 100Hz	-4.19 score on a scale Standard Error 2.41
Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration. PC6 25Hz	-2.23 score on a scale Standard Error 1.87
Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration. Sham	-3.74 score on a scale Standard Error 1.77

SECONDARY outcome

Timeframe: Surveys taking less than 1 minute were taken at maximum-tolerated distension during treatment. Because between sessions, participants had 1-3 weeks off, the maximum time between 1 survey and another was 12 weeks.

Population: For each of the rows of data below, data from 19 participants at one treatment are compared with data from either 19 or 18 participants in the other treatment.

VAS surveys, a pain scale from 0 (lowest) to 10 (highest), were taken to assess efficacy of treatment on a 10-point scale. The minimum possible score is 0 and the maximum possible score is 80, if a participant experienced 10/10 pain. These scores, collected at maximum distension during treatment, were compared between modalities of body position (ST36 or PC6), frequency (100 Hz or 25 Hz), and sham for each individual. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. Analysis is shown as a difference in treatment-induced change between different treatment modalities rather than a comparison between the average pain scores under 1 treatment or another for the group as a whole.

Outcome measures

Outcome measures
Measure	Subjects With IBS-C n=19 Participants All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 and 3 weeks apart. Transcutaneous Electrical Acustimulation (TEA): Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session.
Change in Individual's Pain as Measured by Visual Analog Scale (VAS) Surveys at Max Distension During 1 Treatment Compared to Their Own Pain During a Different Treatment. Change in VAS per person: value at ST36 100Hz minus value at ST36 25Hz	-6.80 score on a scale Standard Error 2.33
Change in Individual's Pain as Measured by Visual Analog Scale (VAS) Surveys at Max Distension During 1 Treatment Compared to Their Own Pain During a Different Treatment. Change in VAS per person: value at ST36 100Hz minus value at PC6 100Hz	-3.55 score on a scale Standard Error 2.11
Change in Individual's Pain as Measured by Visual Analog Scale (VAS) Surveys at Max Distension During 1 Treatment Compared to Their Own Pain During a Different Treatment. Change in VAS per person: value at ST36 100Hz minus value at PC6 25Hz	-5.51 score on a scale Standard Error 1.84
Change in Individual's Pain as Measured by Visual Analog Scale (VAS) Surveys at Max Distension During 1 Treatment Compared to Their Own Pain During a Different Treatment. Change in VAS per person: value at ST36 100Hz minus value at Sham	-3.99 score on a scale Standard Error 1.79
Change in Individual's Pain as Measured by Visual Analog Scale (VAS) Surveys at Max Distension During 1 Treatment Compared to Their Own Pain During a Different Treatment. Change in VAS per person: value at ST36 25Hz minus value at PC6 100Hz	3.25 score on a scale Standard Error 2.62
Change in Individual's Pain as Measured by Visual Analog Scale (VAS) Surveys at Max Distension During 1 Treatment Compared to Their Own Pain During a Different Treatment. Change in VAS per person: value at ST36 25Hz minus value at PC6 25Hz	1.29 score on a scale Standard Error 2.35
Change in Individual's Pain as Measured by Visual Analog Scale (VAS) Surveys at Max Distension During 1 Treatment Compared to Their Own Pain During a Different Treatment. Change in VAS per person: value at ST36 25Hz minus value at Sham	2.80 score on a scale Standard Error 2.30
Change in Individual's Pain as Measured by Visual Analog Scale (VAS) Surveys at Max Distension During 1 Treatment Compared to Their Own Pain During a Different Treatment. Change in VAS per person: value at PC6 100Hz minus value at PC6 25Hz	-1.96 score on a scale Standard Error 2.14
Change in Individual's Pain as Measured by Visual Analog Scale (VAS) Surveys at Max Distension During 1 Treatment Compared to Their Own Pain During a Different Treatment. Change in VAS per person: value at PC6 100Hz minus value at Sham	-0.45 score on a scale Standard Error 2.09
Change in Individual's Pain as Measured by Visual Analog Scale (VAS) Surveys at Max Distension During 1 Treatment Compared to Their Own Pain During a Different Treatment. Change in VAS per person: value at PC6 25Hz minus value at Sham	1.52 score on a scale Standard Error 1.82

SECONDARY outcome

Population: Data from participants who did not reach a maximum tolerance at a preset maximum distension pressure of 60 mmHg were not analyzed. For some participants, the barostat was unable to provide complete data to allow analysis.

The barostat device will measure the volume changes in the rectum during controlled distension, as measured in milliliters. The study participant's maximum volume will be compared to tolerance pre and post TEA. A higher number corresponds to a higher maximum volume. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' maximum volume may have changed over time between sessions. Each change value listed below represents the mean of the differences between each participant's maximum volume with stimulation and that participant's baseline for that day. Analysis is shown as a single arm rather than a cross-over because the averages below are calculated from the change in each participant's maximum volume compared only to their own maximum volume.

Outcome measures

Outcome measures
Measure	Subjects With IBS-C n=19 Participants All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 and 3 weeks apart. Transcutaneous Electrical Acustimulation (TEA): Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session.
Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. Change in max vol per participant in mL of the rectum during ST36 100Hz minus max vol at baseline	-2.31 mL Standard Error 13.59
Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. Change in max vol per participant in mL of the rectum during ST36 25Hz minus max vol at baseline	14.08 mL Standard Error 8.74
Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. Change in max vol per participant in mL of the rectum during PC6 100Hz minus max vol at baseline	11.83 mL Standard Error 8.10
Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. Change in max vol per participant in mL of the rectum during PC6 25Hz minus max vol at baseline	-1.56 mL Standard Error 10.01
Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. Change in max vol per participant in mL of the rectum during sham minus max vol at baseline	13.48 mL Standard Error 8.75

SECONDARY outcome

Population: In the case of PC6 100 HZ, post-treatment value is missing for 1 participant.

The barostat device measured the pressure changes in the rectum during controlled distension, as measured in mmHg. Values below show the pressure at which each participant experienced first sensation of the rectum during stimulation minus the pressure at which each participant experienced first sensation at baseline. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' pressure may have changed over time between sessions. Analysis is shown as a single arm rather than a cross-over because the averages below are calculated from the change in each participant's pressure compared only to their own pressure.