DEMMMI, Nine-Hole-PEG-Test, mRSNCT03264742
Ghrelintrial With Patients With Stroke
An observational study of DEMMMI, Nine-Hole-PEG-Test, mRS and Stroke, Acute, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
Trial summary
Patients are assigned to KSW's Stroke Unit as part of the emergency treatment. There the patients are included in the study and treated according to the concept on the Stroke Unit within the complex treatment. The patients are included after clarification and with the consent of the patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- DEMMMI, Nine-Hole-PEG-Test, mRS, Stroke, Acute
- What is being tested?
- Ghrelin
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2017to 28 Feb 2019
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients with acute ischemic insult with functionally relevant motor Hemisymptomatik up to 7 days after the event at the age from 18 to 90 years with written approval of the participant after occurred clarification
Who may be able to join
- Male and female patients
- acute ischemic insult
- functionally relevant motor hemisymptomatic
- up to 7 days after the event
- age from 18 to 90 years
- written approval of the participant after occurred clarification
Who cannot join
- Dysphagia
- Nutritional-Risk-Screening (NRS) = 3
- Neuro-degenerative illnesses
- Patients with strokes in the past
- Patients with clinically relevant Polyneuropathy
- Patients with walking disturbance on account of mikroangiopathic changes
Show all 9Show fewer
- Patients with psychiatric preillnesses (depression, schizophrenia) and anti- depressive and neuroleptic medication
- Patients with rheumatic illnesses with effects on the walking and Hand function
- Patients with innate and/or acquired substance defects of the brain and/or spinal cord (functionally relevant brain tumour, St. n. Encephalitis, brain damage as an infant)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Trial to Investigate a Neuroprotective Effect of Ghrelin After Acute Ischemic Stroke
Patients are assigned to KSW's Stroke Unit as part of the emergency treatment. There the patients are included in the study and treated according to the concept on the Stroke Unit within the complex treatment. The patients are included after clarification and with the consent of the patients. On the morning after the day of intake, the first determination of the ghrelin takes place in the routine blood sampling. Similarly, 48 hours later and 3 months after the stroke, a blood sampling is performed to determine ghrelin. The De Morton Mobility Index (DEMMI), the 9-hole-peg assay and the modified Rankin Scale (mRS) are determined on the day of admission, on the 3rd day, and three months after stroke. This is done within the framework of the routine clarification and treatment on the Stroke Unit.
Read the detailed description
Ghreline is a peptide hormone which is produced particularly by cells of the stomach mucous membrane and has an appetizing effect. Nevertheless, the last studies in the person as well as in the animal model showed that ghreline as well as receptos of ghreline become exprimated also in neurons. Antiapoptic effects of ghreline, an increase of the endogenous neuro genesis and support of the formation of dendritic synapses could be proved. In a study in the animal model (rats), for example, a neuroprotective effect from ghreline could be proved. Besides, ghreline showed neuro-regenerative effects after a stroke. As a possible mechanism an increased neuro genesis is accepted for this. Now the aim of our study is to be examined whether the patients with an ischemic stroke who have a high ghreline concentration have a better functional outcome. No interventions specific for study take place. It concerns with this research project not a clinical attempt, but a pure blood withdrawal plus survey. Besides, no special risks exist for the patient, because it is found in the routine treatment on the stroke station (Stroke Unit) of the canton hospital of Winterthur and no measures specific for study are carried out.
aims of Project: The aim of this study is to examine Ghrelin concerning his neuroprotective and neuro-regenerative improvement of patients with acute stroke.
Aim dimensions of the project Improvement of the functional Outcomes with patients with acute stroke measured in the De Morton Mobility Index (DEMMI), 9hole-peg-Test and the modified Rankin-Scale (mRS) in relation to the ghreline-serum concentration. In the morning after the admission day the decrease of the first Ghrelintest occurs within the scope of the blood sample as a matter of routine to be carried out. Also 48 hours later and 3 months after the blow attack a blood sample for testing the ghreline concentration is taken as a mater of routine.
The patients are recruited within the scope of the treatment on the stroke station of the canton hospital of Winterthur Duration of the project 2 Years intended time of the beginning of the project (FPFV): 01/09/2016 prospective time of the end of the project (LPLV): 31/08/2018 The Stroke Unit (stroke station) of the canton hospital of Winterthur exists since 01.04. 2013 and looks meanwhile yearly after more than 400 patients with cerebrovaskulären illnesses. To the-chance a qualified and experienced nursing staff stands beside the medical care, neuro-logically experienced therapists as well as a suitable infrastructure which enables to raise the data necessary for the study qualitatively on the highest level
- Conditions
- DEMMMI, Nine-Hole-PEG-Test, mRS, Stroke, Acute
- Being tested
- Ghrelin
- Keywords
- ghreline, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GhrelinOther
The patients are assigned within the scope of the admission according to emergency to the treatment and clarification on the Stroke Unit of the KSW. There the patients are enclosed in the study and are examined according to the draught on the Stroke Unit within the scope of the complex treatment. The inclusion of the patients occurs after clarification and in the consent of the patients. In the morning after the admission day the decrease of the first blood test occurs within the scope of the blood sample as a matter of routine to be carried out for the Ghrelinbestimmung. Also 48 H occurs after the first withdrawal and 3 months after the stroke a blood sample to the regulation of Ghrelin.
What is being measured
The primary outcome is the main question the study is designed to answer.
De Morton Mobility Index (DEMMI)
The de Morton Mobility Index (DEMMI) is an internationally well-established, unidimensional measure of mobility with good psychometric properties.
Measured: On the first, the third day and 3 months after including in the study, the time for the DEMMI takes about 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Apr 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Why it stopped: recruitment too low
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 DEMMMI, Nine-Hole-PEG-Test, mRSStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Ballmer, Principal investigator, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264742
- Sponsor's protocol ID
- ID 2017-00387
- Status last verified
- Feb 2019
- First submitted
- 17 Aug 2017
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cummings DE. Ghrelin and the short- and long-term regulation of appetite and body weight. Physiol Behav. 2006 Aug 30;89(1):71-84. doi: 10.1016/j.physbeh.2006.05.022. Epub 2006 Jul 21.
PubMed 16859720Spencer SJ, Miller AA, Andrews ZB. The role of ghrelin in neuroprotection after ischemic brain injury. Brain Sci. 2013 Mar 19;3(1):344-59. doi: 10.3390/brainsci3010344.
PubMed 24961317
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Trial to Investigate a Neuroprotective Effect of Ghrelin After Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03264742
- Acronym / sponsor ID
- ID 2017-00387
- Conditions
- DEMMMI, Nine-Hole-PEG-Test, mRS, Stroke, Acute
- Keywords
- ghreline, stroke
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment too low
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 29 Aug 2017 (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.
Patients are assigned to KSW's Stroke Unit as part of the emergency treatment. There the patients are included in the study and treated according to the concept on the Stroke Unit within the complex treatment. The patients are included after clarification and with the consent of the patients. On the morning after the day of intake, the first determination of the ghrelin takes place in the routine blood sampling. Similarly, 48 hours later and 3 months after the stroke, a blood sampling is performed to determine ghrelin. The De Morton Mobility Index (DEMMI), the 9-hole-peg assay and the modified Rankin Scale (mRS) are determined on the day of admission, on the 3rd day, and three months after stroke. This is done within the framework of the routine clarification and treatment on the Stroke Unit.
Detailed description
Ghreline is a peptide hormone which is produced particularly by cells of the stomach mucous membrane and has an appetizing effect. Nevertheless, the last studies in the person as well as in the animal model showed that ghreline as well as receptos of ghreline become exprimated also in neurons. Antiapoptic effects of ghreline, an increase of the endogenous neuro genesis and support of the formation of dendritic synapses could be proved. In a study in the animal model (rats), for example, a neuroprotective effect from ghreline could be proved. Besides, ghreline showed neuro-regenerative effects after a stroke. As a possible mechanism an increased neuro genesis is accepted for this. Now the aim of our study is to be examined whether the patients with an ischemic stroke who have a high ghreline concentration have a better functional outcome. No interventions specific for study take place. It concerns with this research project not a clinical attempt, but a pure blood withdrawal plus survey. Besides, no special risks exist for the patient, because it is found in the routine treatment on the stroke station (Stroke Unit) of the canton hospital of Winterthur and no measures specific for study are carried out.
aims of Project: The aim of this study is to examine Ghrelin concerning his neuroprotective and neuro-regenerative improvement of patients with acute stroke.
Aim dimensions of the project Improvement of the functional Outcomes with patients with acute stroke measured in the De Morton Mobility Index (DEMMI), 9hole-peg-Test and the modified Rankin-Scale (mRS) in relation to the ghreline-serum concentration. In the morning after the admission day the decrease of the first Ghrelintest occurs within the scope of the blood sample as a matter of routine to be carried out. Also 48 hours later and 3 months after the blow attack a blood sample for testing the ghreline concentration is taken as a mater of routine.
The patients are recruited within the scope of the treatment on the stroke station of the canton hospital of Winterthur Duration of the project 2 Years intended time of the beginning of the project (FPFV): 01/09/2016 prospective time of the end of the project (LPLV): 31/08/2018 The Stroke Unit (stroke station) of the canton hospital of Winterthur exists since 01.04. 2013 and looks meanwhile yearly after more than 400 patients with cerebrovaskulären illnesses. To the-chance a qualified and experienced nursing staff stands beside the medical care, neuro-logically experienced therapists as well as a suitable infrastructure which enables to raise the data necessary for the study qualitatively on the highest level
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients with acute ischemic insult with functionally relevant motor Hemisymptomatik up to 7 days after the event at the age from 18 to 90 years with written approval of the participant after occurred clarification
Key inclusion criteria (6 listed)
- Male and female patients
- acute ischemic insult
- functionally relevant motor hemisymptomatic
- up to 7 days after the event
- age from 18 to 90 years
Key exclusion criteria (9 listed)
- Dysphagia
- Nutritional-Risk-Screening (NRS) = 3
- Neuro-degenerative illnesses
- Patients with strokes in the past
- Patients with clinically relevant Polyneuropathy
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 |
|---|---|---|
| GhrelinThe patients are assigned within the scope of the admission according to emergency to the treatment and clarification on the Stroke Unit of the KSW. There the patients are enclosed in the study and are examined according to the draught on the Stroke Unit within the scope of the complex treatment. The inclusion of the patients occurs after clarification and in the consent of the patients. In the morning after the admission day the decrease of the first blood test occurs within the scope of the blood sample as a matter of routine to be carried out for the Ghrelinbestimmung. Also 48 H occurs after the first withdrawal and 3 months after the stroke a blood sample to the regulation of Ghrelin. | Other | – |
Primary outcome
De Morton Mobility Index (DEMMI)
Time frame: On the first, the third day and 3 months after including in the study, the time for the DEMMI takes about 20 minutes
The de Morton Mobility Index (DEMMI) is an internationally well-established, unidimensional measure of mobility with good psychometric properties.
Results and safety
The study was stopped early (reason given: recruitment too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Background: PubMed 16859720Cummings DE. Ghrelin and the short- and long-term regulation of appetite and body weight. Physiol Behav. 2006 Aug 30;89(1):71-84. doi: 10.1016/j.physbeh.2006.05.022. Epub 2006 Jul 21.
- Background: PubMed 24961317Spencer SJ, Miller AA, Andrews ZB. The role of ghrelin in neuroprotection after ischemic brain injury. Brain Sci. 2013 Mar 19;3(1):344-59. doi: 10.3390/brainsci3010344.
- Individual participant dataSharing planned: Undecided
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.
Peter Ballmer principal investigator
Kantonsspital Winterthur KSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DEMMMI, Nine-Hole-PEG-Test, mRS and Stroke, Acute, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
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 6 inclusion and 9 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 1 Mar 2019. 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 Switzerland. 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?
The study was stopped early (reason given: recruitment too low). 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?
De Morton Mobility Index (DEMMI) (time frame: On the first, the third day and 3 months after including in the study, the time for the DEMMI takes about 20 minutes). 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 NCT03264742, 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 1 Mar 2019.