Understanding unpleasant sensations in ALS patients during procedures
Perception of Unpleasant Sensations in Patients With Amyotrophic Lateral Sclerosis During Procedures Performed in Clinical Trials
Istituto Auxologico Italiano · NCT06325865
This study is trying to understand the uncomfortable feelings that ALS patients have during clinical trial procedures to help make future trials easier for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano (other) |
| Locations | 1 site (Milano) |
| Trial ID | NCT06325865 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the unpleasant sensations experienced by patients with Amyotrophic Lateral Sclerosis (ALS) during clinical trial procedures. By conducting interviews, the study seeks to identify specific types of pain or discomfort that may deter patients from participating in clinical trials. The findings could help improve patient experience and retention in future ALS studies. The study focuses on patients who have a functional understanding of the procedures involved and have previously participated in clinical trials.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with spinal or bulbar ALS who can understand Italian and have previously participated in clinical studies.
Not a fit: Patients with clinically relevant cognitive dysfunction or severe anxiety and depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the design of clinical trials for ALS, leading to improved patient comfort and higher participation rates.
How similar studies have performed: While studies on patient perceptions during clinical procedures exist, this specific focus on ALS and its associated discomforts is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Milano
- Istituto Auxologico italiano IRCSS, San Luca Hospital — Milano, Italy (RECRUITING)
Study contacts
- Study coordinator: Martina Sodano
- Email: m.sodano@auxologico.it
- Phone: +3902619111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amyotrophic Lateral Sclerosis, Study procedures