Amyotrophic Lateral SclerosisPESALSNCT06325865
Perception of Unpleasant Sensations During Study Procedures in ALS Patients
An observational study of Amyotrophic Lateral Sclerosis, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
Diagnosis of Amyotrophic Lateral Sclerosis (ALS) is considered a traumatic life event for both the patient and their next-of-kin/carers, due to the lack of treatment. Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. 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?
- Interview
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 19 Apr 2023to 24 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Amyotrophic Lateral Sclerosis (ALS) patients who are currently participating in interventional clinical studies or who have particpated in the recent past.
Who may be able to join
- Spinal or bulbar Amyotrophic Lateral Sclerosis (ALS)
- Age > 18 years
- Adequate understanding of Italian language
- Full understanding of the study
- Informed consent signed
- Current or past participation in interventional clinical studies
- Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) score of item # 4 ≥ 2, or score of item #1 ≥ 1
Who cannot join
- Clinically relevant cognitive dysfunction
- Inability to answer orally or by writing to the questions of the interview
- Hospital Anxiety and Depression Scale (HADS) scale ≥ 11
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perception of Unpleasant Sensations in Patients With Amyotrophic Lateral Sclerosis During Procedures Performed in Clinical Trials
Diagnosis of Amyotrophic Lateral Sclerosis (ALS) is considered a traumatic life event for both the patient and their next-of-kin/carers, due to the lack of treatment. Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. Research protocols may involve routine diagnostic and/or therapeutic procedures which the patients may be already aware of and, therefore, expecting specific sensations. These could compromise participation or drop-out rate. Despite everything, participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures, through preferential access compared to other patients.
Aim of this study is to investigate the unpleasant sensations perceived by ALS patients during procedures in clinical trials. Analysing what type of pain/discomfort frightens patients during diagnostic and/or therapeutic procedures, including the different methods of administration of the study drug. Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures. Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required. Provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale. Create and implement an ALS-specific pain scale accounting for its impact on daily activities, aiding an interdisciplinary approach of pain management. Identify the best pain management strategies and compliance techniques to address ALS, not merely in clinical trials. Provide the best individualized care for ALS patients improving their quality of life and mental state.
This is a descriptive phenomenological study and data will be analyzed according to Sundler's method. Based on the experience of the researchers and the recommendations proposed by Sandelowski, a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference. Data collection will be carried out through in-depth semi-structured interviews recorded (13 open-ended questions after the execution of the procedures).
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Interview
- Keywords
- Study procedures
- 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.
InterviewOther
Interview with ALS patient in which the experiences of unpleasant sensations or pain during study procedures are assessed in a qualitative manner.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of experience of unpleasant sensations or pain
Prevalence of reported experience of unpleasant sensations orn pain during study procedures
Measured: At enrollment
Study procedure that causes unpleasant sensations or pain
Qualitative description of study procedure that causes unpleasant sensations or pain
Measured: At enrollment
Duration of unpleasant sensations or pain caused by the study procedure
Duration in minutes of unpleasant sensations or pain caused by the study procedure
Measured: At enrollment
Secondary outcomes (2)
HADS score
Score on Hospital Anxiety and Depression Scale (HADS) scale
Measured: At enrollment
ALSFRS score
Score on Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) scale
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start19 Apr 2023
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325865
- Sponsor's protocol ID
- 23C305
- Acronym
- PESALS
- Status last verified
- Nov 2025
- First submitted
- 16 Mar 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Unpleasant Sensations in Patients With Amyotrophic Lateral Sclerosis During Procedures Performed in Clinical Trials
- ClinicalTrials.gov ID
- NCT06325865
- Acronym / sponsor ID
- PESALS / 23C305
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Study procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 22 Mar 2024 (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.
Diagnosis of Amyotrophic Lateral Sclerosis (ALS) is considered a traumatic life event for both the patient and their next-of-kin/carers, due to the lack of treatment. Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. Research protocols may involve routine diagnostic and/or therapeutic procedures which the patients may be already aware of and, therefore, expecting specific sensations. These could compromise participation or drop-out rate. Despite everything, participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures, through preferential access compared to other patients.
Aim of this study is to investigate the unpleasant sensations perceived by ALS patients during procedures in clinical trials. Analysing what type of pain/discomfort frightens patients during diagnostic and/or therapeutic procedures, including the different methods of administration of the study drug. Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures. Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required. Provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale. Create and implement an ALS-specific pain scale accounting for its impact on daily activities, aiding an interdisciplinary approach of pain management. Identify the best pain management strategies and compliance techniques to address ALS, not merely in clinical trials. Provide the best individualized care for ALS patients improving their quality of life and mental state.
This is a descriptive phenomenological study and data will be analyzed according to Sundler's method. Based on the experience of the researchers and the recommendations proposed by Sandelowski, a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference. Data collection will be carried out through in-depth semi-structured interviews recorded (13 open-ended questions after the execution of the procedures).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Amyotrophic Lateral Sclerosis (ALS) patients who are currently participating in interventional clinical studies or who have particpated in the recent past.
Key inclusion criteria (7 listed)
- Spinal or bulbar Amyotrophic Lateral Sclerosis (ALS)
- Age > 18 years
- Adequate understanding of Italian language
- Full understanding of the study
- Informed consent signed
Key exclusion criteria (3 listed)
- Clinically relevant cognitive dysfunction
- Inability to answer orally or by writing to the questions of the interview
- Hospital Anxiety and Depression Scale (HADS) scale ≥ 11
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 |
|---|---|---|
| InterviewInterview with ALS patient in which the experiences of unpleasant sensations or pain during study procedures are assessed in a qualitative manner. | Other | – |
Primary outcome
Prevalence of experience of unpleasant sensations or pain
Time frame: At enrollment
Prevalence of reported experience of unpleasant sensations orn pain during study procedures
Study procedure that causes unpleasant sensations or pain
Time frame: At enrollment
Qualitative description of study procedure that causes unpleasant sensations or pain
Duration of unpleasant sensations or pain caused by the study procedure
Time frame: At enrollment
Duration in minutes of unpleasant sensations or pain caused by the study procedure
2 secondary outcomes
HADS score
Time frame: At enrollment
ALSFRS score
Time frame: At enrollment
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 18 Nov 2025.
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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?
An observational study of Amyotrophic Lateral Sclerosis, run by Istituto Auxologico Italiano at 1 site in Italy.
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 7 inclusion and 3 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 18 Nov 2025. 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 Italy. 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 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?
Prevalence of experience of unpleasant sensations or pain (time frame: At enrollment). The study lists 3 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 18 Nov 2025.