Amyotrophic Lateral SclerosisPhase 1/2NCT03481348
Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis
A Phase 1/2 study testing Pharyngeal Electrical Stimulation in people with Amyotrophic Lateral Sclerosis, run by University of Ulm at 1 site in Germany.
Trial summary
During the course of ALS most patients develop swallowing deficits. In this pilot study we investigate if dysphagia in ALS can be improved by Pharyngeal Electrical Stimulation (PES). PES is Communauté Européenne (CE-) certificated and has been approved for treatment of neurological, oropharyngeal dysphagia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Pharyngeal Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2018to 21 Jul 2020
- Phase
- Phase 1/2
- 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
- possible, probable or definite ALS according to the revised El Escorial criteria (Brooks et al. 2000)
- age >18 years
- able to understand all information and to give full consent according to good clinical practice (GCP)
- moderate ot severe dysphagia, defined by a mean value (all consistencies) of 4
Who cannot join
- concurrent participation in another interventional trial
- tracheostomy
- severe psychiatric disorder or clinically manifest dementia
- pulmonal or cardial disorder which constitutes a risk when inserting the tube into the pharynx
- permanent cardiac pacemaker or defibrillator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis: A Pilot Study With 20 Patients
During the course of ALS most patients develop swallowing deficits. In this pilot study we investigate if dysphagia in ALS can be improved by Pharyngeal Electrical Stimulation (PES). PES is Communauté Européenne (CE-) certificated and has been approved for treatment of neurological, oropharyngeal dysphagia. During PES, electrical stimuli are applied at the pharynx via a nasogastral tube with the aim of triggering reorganization processes in damaged brain structures. There is evidence of a positive effect of PES in Stroke and Multiple Sclerosis patients.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Pharyngeal Electrical Stimulation
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharyngeal Electrical StimulationDevice
Pharyngeal Electrical Stimulation is applied at the pharynx via a nasogastral tube for 10 minutes per day on 3 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Pharyngeal Electrical Stimulation | Experimental | PES for 10 minutes per day on 3 consecutive days in addition to standard therapy (logopedic counselling, advice for nutrition, learning of swallowing techniques) Receives: Device: Pharyngeal Electrical Stimulation |
| Control | No intervention | Standard therapy (logopedic counselling, advice for nutrition, learning of swallowing techniques) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration Aspiration Scale (PAS) Score
Degree of Penetration and Aspiration evaluated by fiberendoscopic evaluation of swallowing (FEES)
Measured: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Secondary outcomes (6)
Swallowing-Quality of Life Score (SWAL-QOL)
swallowing-specific quality of life questionnaire
Measured: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Schluckbeeinträchtigungs-Skala (SBS) Score
Clinical scale to evaluate severity of dysphagia
Measured: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Functional Oral Intake Scale (FOIS) Score
Clinical scale to evaluate the impairment of oral food intake
Measured: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Dysphagia Severity Rating Scale (DSRS) Score
Clinical scale to evaluate severity of dysphagia
Measured: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALS-FRS-R)
Clinical scale to evaluate the severity of symptoms in ALS
Measured: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Frequency of Adverse Events
Frequency of Adverse Events
Measured: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Feb 2018
- Primary completion21 Jul 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Christian Ludolph, Prof., University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481348
- Sponsor's protocol ID
- PES-ALS
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2018
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. doi: 10.1080/146608200300079536. No abstract available.
PubMed 11464847Herrmann C, Schradt F, Lindner-Pfleghar B, Schuster J, Ludolph AC, Dorst J. Pharyngeal electrical stimulation in amyotrophic lateral sclerosis: a pilot study. Ther Adv Neurol Disord. 2022 Feb 8;15:17562864211068394. doi: 10.1177/17562864211068394. eCollection 2022.
PubMed 35154390
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis: A Pilot Study With 20 Patients
- ClinicalTrials.gov ID
- NCT03481348
- Acronym / sponsor ID
- PES-ALS
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 29 Mar 2018 (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.
During the course of ALS most patients develop swallowing deficits. In this pilot study we investigate if dysphagia in ALS can be improved by Pharyngeal Electrical Stimulation (PES). PES is Communauté Européenne (CE-) certificated and has been approved for treatment of neurological, oropharyngeal dysphagia. During PES, electrical stimuli are applied at the pharynx via a nasogastral tube with the aim of triggering reorganization processes in damaged brain structures. There is evidence of a positive effect of PES in Stroke and Multiple Sclerosis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharyngeal Electrical Stimulation | Experimental | Device: Pharyngeal Electrical StimulationPES for 10 minutes per day on 3 consecutive days in addition to standard therapy (logopedic counselling, advice for nutrition, learning of swallowing techniques) |
| Control | No intervention | –Standard therapy (logopedic counselling, advice for nutrition, learning of swallowing techniques) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- possible, probable or definite ALS according to the revised El Escorial criteria (Brooks et al. 2000)
- age >18 years
- able to understand all information and to give full consent according to good clinical practice (GCP)
- moderate ot severe dysphagia, defined by a mean value (all consistencies) of 4
Key exclusion criteria (5 listed)
- concurrent participation in another interventional trial
- tracheostomy
- severe psychiatric disorder or clinically manifest dementia
- pulmonal or cardial disorder which constitutes a risk when inserting the tube into the pharynx
- permanent cardiac pacemaker or defibrillator
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 |
|---|---|---|
| Pharyngeal Electrical StimulationPharyngeal Electrical Stimulation is applied at the pharynx via a nasogastral tube for 10 minutes per day on 3 consecutive days. | Device | Pharyngeal Electrical Stimulation |
Primary outcome
Penetration Aspiration Scale (PAS) Score
Time frame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Degree of Penetration and Aspiration evaluated by fiberendoscopic evaluation of swallowing (FEES)
6 secondary outcomes
Swallowing-Quality of Life Score (SWAL-QOL)
Time frame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Schluckbeeinträchtigungs-Skala (SBS) Score
Time frame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Functional Oral Intake Scale (FOIS) Score
Time frame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Dysphagia Severity Rating Scale (DSRS) Score
Time frame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALS-FRS-R)
Time frame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Frequency of Adverse Events
Time frame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Background: PubMed 11464847Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. doi: 10.1080/146608200300079536. No abstract available.
- Derived from this study: PubMed 35154390Herrmann C, Schradt F, Lindner-Pfleghar B, Schuster J, Ludolph AC, Dorst J. Pharyngeal electrical stimulation in amyotrophic lateral sclerosis: a pilot study. Ther Adv Neurol Disord. 2022 Feb 8;15:17562864211068394. doi: 10.1177/17562864211068394. eCollection 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pharyngeal Electrical Stimulation in people with Amyotrophic Lateral Sclerosis, run by University of Ulm at 1 site in Germany.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 8 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 1 site in Germany. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Penetration Aspiration Scale (PAS) Score (time frame: day 0 (=before PES), day 4 (=after PES), day 7, day 21, day 90). 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 NCT03481348, which also lists 2 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 8 Mar 2021.