Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 15, 2021

Primary Completion Date

September 30, 2025

Study Completion Date

December 30, 2025

Conditions
Amyotrophic Lateral Sclerosis
Interventions
DIAGNOSTIC_TEST

Skin biopsy

A punch skin biopsy of 3mm will be used to analyze cutaneous innervation

DIAGNOSTIC_TEST

Cardiovascular Reflexes testing

Cardiovascular reflex tests including deep breathing, head-up Tilt, standing, isometric exercises, mental arithmetic and Valsalva maneuver.

DIAGNOSTIC_TEST

Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms

We'll characterize patients' symptoms through the administration of clinical scales such as: SCOPA-AUT autonomic symptoms scale; Brief Pain Inventory questionnaire

DIAGNOSTIC_TEST

Dinamic Sweat Test

Test for the functional assessment of postganglionic sudomotor pathway

Trial Locations (2)

80131

RECRUITING

Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II, Napoli

82037

RECRUITING

ICS Maugeri - IRCCS of Telese Terme, Telese Terme

All Listed Sponsors
lead

Istituti Clinici Scientifici Maugeri SpA

OTHER