Spinal Cord InjuriesNCT04627168
Trancutaneous Abdominal Stimulation on Bowel Function.
A study testing Non-invasive, surface electrical stimulation device, DS5 Digitimer in people with Spinal Cord Injuries and Constipation, run by Amol Soin, M.D., MBA at 1 site in United States.
Trial summary
This is a prospective, single-center, feasibility study to determine the sensations elicited by non-invasive abdominal electrical stimulation and its effects on bowel function in spinal cord injured individuals and in able-bodied persons with chronic constipation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Constipation
- What is being tested?
- Non-invasive, surface electrical stimulation device, DS5 Digitimer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2020to 28 Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For spinal cord injury subject group:
- Traumatic or non-traumatic spinal cord injury;
- Constipation;
- Motor-complete or motor-incomplete spinal cord injury;
- Quadriplegia or paraplegia;
- Post-injury time ≥ 1 year;
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- Neurogenic Bowel Dysfunction Score ≥ 7.
- For able-bodied subject group:
- Diagnosis of intestinal constipation according to the Rome IV criteria;
- Chronic constipation as defined by < 3 bowel movements per week for > 3 months.
- For both subject groups:
- Can read, understand and willingly sign an Institutional Review Board approved informed consent document that describes the study's risks and benefits.
Who cannot join
- Presence of any organic cause for intestinal constipation;
- Have chronic fecal incontinence;
- Have skin infection/lesion in the area of electrode application or systemic skin disease;
- Have an implanted electronic device (such as heart pacemaker, insulin or baclofen pump, etc);
- Have symptomatic cardiac disease;
- Have uncontrolled diabetes;
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- Presence of abdominal hernia;
- Have a stoma, rectal tear, or untreated hemorrhoids;
- Have a significant psychiatric disorder;
- For female subjects, being pregnant, actively planning a pregnancy or breast-feeding a child;
- Be participating in another clinical study that would confound data analysis;
- Have a cognitive impairment or exhibits any characteristic that would limit the study candidate's ability to complete study assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Transcutaneous Abdominal Stimulation on Bowel Function in Persons With Spinal Cord Injury and in Able-bodied Persons With Chronic Constipation.
This is a prospective, single-center, feasibility study to determine the sensations elicited by non-invasive abdominal electrical stimulation and its effects on bowel function in spinal cord injured individuals and in able-bodied persons with chronic constipation. Electrical stimulation will be delivered through commercially available equipment to each subject during a single site visit.
Read the detailed description
This is a prospective, single-center, treatment feasibility study to determine the efficacy of electrical stimulation for bowel functions. The study will determine sensations elicited by non-invasive, transcutaneous abdominal electrical stimulation and its effects on bowel function in spinal cord injured individuals and in able-bodied persons with chronic constipation. The electrical stimulation will be delivered through commercially available equipment to each subject during a single site visit. Visits are anticipated to be no more than 5 hours.
- Conditions
- Spinal Cord Injuries, Constipation
- Being tested
- Non-invasive, surface electrical stimulation device, DS5 Digitimer
- Keywords
- spinal cord injury, stimulation, constipation
- Medical subject headings
- Spinal Cord Injuries, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive, surface electrical stimulation device, DS5 DigitimerDevice
Transcutaneous abdominal electrical stimulation will be delivered through the commercially available equipment, a DS5 Digitimer.
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord injured persons | Experimental | Persons living with spinal cord injury presenting with constipation due to neurogenic bowel dysfunction. Receives: Device: Non-invasive, surface electrical stimulation device, DS5 Digitimer |
| Persons without neurogenic bowel dysfunction | Experimental | Abled-bodied persons with chronic constipation. Receives: Device: Non-invasive, surface electrical stimulation device, DS5 Digitimer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the occurrence of first stool
The time between the onset of transcutaneous abdominal electrical stimulation and the first stool will be measured.
Measured: 7 days
Total defecation time (duration)
The time (duration) to complete total defecation following the stimulation.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start7 Oct 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be assigned to 1 of 2 groups. The first subject group will include spinal cord injured persons presenting with constipation, the second group - able-bodied persons with chronic constipation. In both groups, subjects will receive transcutaneous abdominal electrical stimulation that will be delivered through commercially available equipment.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amol Soin, M.D., MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amol Soin, M.D., MBA, Ohio Pain Clinic
- Investigators
- Amol Soin, MD, Principal investigator, Ohio Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627168
- Sponsor's protocol ID
- MM 100-1
- Status last verified
- Jun 2022
- First submitted
- 1 Nov 2020
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcutaneous Abdominal Stimulation on Bowel Function in Persons With Spinal Cord Injury and in Able-bodied Persons With Chronic Constipation.
- ClinicalTrials.gov ID
- NCT04627168
- Acronym / sponsor ID
- MM 100-1
- Conditions
- Spinal Cord Injuries, Constipation
- Keywords
- spinal cord injury, stimulation, constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Amol Soin, M.D., MBAUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 13 Nov 2020 (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 is a prospective, single-center, feasibility study to determine the sensations elicited by non-invasive abdominal electrical stimulation and its effects on bowel function in spinal cord injured individuals and in able-bodied persons with chronic constipation. Electrical stimulation will be delivered through commercially available equipment to each subject during a single site visit.
Detailed description
This is a prospective, single-center, treatment feasibility study to determine the efficacy of electrical stimulation for bowel functions. The study will determine sensations elicited by non-invasive, transcutaneous abdominal electrical stimulation and its effects on bowel function in spinal cord injured individuals and in able-bodied persons with chronic constipation. The electrical stimulation will be delivered through commercially available equipment to each subject during a single site visit. Visits are anticipated to be no more than 5 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be assigned to 1 of 2 groups. The first subject group will include spinal cord injured persons presenting with constipation, the second group - able-bodied persons with chronic constipation. In both groups, subjects will receive transcutaneous abdominal electrical stimulation that will be delivered through commercially available equipment.
| Arm | Type | Receives |
|---|---|---|
| Spinal cord injured persons | Experimental | Device: Non-invasive, surface electrical stimulation device, DS5 DigitimerPersons living with spinal cord injury presenting with constipation due to neurogenic bowel dysfunction. |
| Persons without neurogenic bowel dysfunction | Experimental | Device: Non-invasive, surface electrical stimulation device, DS5 DigitimerAbled-bodied persons with chronic constipation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- For spinal cord injury subject group:
- For able-bodied subject group:
- For both subject groups:
- Can read, understand and willingly sign an Institutional Review Board approved informed consent document that describes the study's risks and benefits.
Key exclusion criteria (12 listed)
- Presence of any organic cause for intestinal constipation;
- Have chronic fecal incontinence;
- Have skin infection/lesion in the area of electrode application or systemic skin disease;
- Have an implanted electronic device (such as heart pacemaker, insulin or baclofen pump, etc);
- Have symptomatic cardiac disease;
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 |
|---|---|---|
| Non-invasive, surface electrical stimulation device, DS5 DigitimerTranscutaneous abdominal electrical stimulation will be delivered through the commercially available equipment, a DS5 Digitimer. | Device | Persons without neurogenic bowel dysfunction, Spinal cord injured persons |
Primary outcome
Duration of the occurrence of first stool
Time frame: 7 days
The time between the onset of transcutaneous abdominal electrical stimulation and the first stool will be measured.
Total defecation time (duration)
Time frame: 7 days
The time (duration) to complete total defecation following the stimulation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- 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.
Amol Soin, MD principal investigator
Ohio Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive, surface electrical stimulation device, DS5 Digitimer in people with Spinal Cord Injuries and Constipation, run by Amol Soin, M.D., MBA 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 12 inclusion and 12 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 13 Jun 2022. 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?
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?
Duration of the occurrence of first stool (time frame: 7 days). The study lists 2 primary outcomes in all. 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 13 Jun 2022.