Status:

COMPLETED

Anti-Cholinergic Receptors Antibodies, Autonomic Profile and Dysautonomia Symptoms in PAF, ALS and POTS (DISAUT-AB)

Lead Sponsor:

Istituto Clinico Humanitas

Collaborating Sponsors:

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Fondazione Salvatore Maugeri

Conditions:

Pure Autonomic Failure

Amyotrophic Lateral Sclerosis

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Anti alfa-3 and alfa-7 ganglionic cholinergic receptors (anti-AChRs) antibodies (Abs) plasma removal by plasmapheresis (1,2) acutely improved dysautonomia symptoms in case reports with Pure Autonomic ...

Detailed Description

PAF is a rare neurodegenerative disorder characterized by symptoms due to sympathetic failure, such as orthostatic hypotension and syncope, and deficient parasympathetic activity such as constipation,...

Eligibility Criteria

Inclusion

  • • Patients, older than 18 years affected by PAF, ALS and POTS, with dysautonomia symptoms assessed by clinical evaluation and by the Composite Autonomic Scoring Scale (CASS)

Exclusion

  • Hepatic, renal, heart and other secondary causes of autonomic dysfunction
  • History/familiarity with seizures
  • Atrial fibrillation and other relevant cardiac rhythm disturbances
  • Diabetes
  • Other neurological or psychiatric diseases
  • Pacemakers or other electronic implants inserted into the body
  • Coronary disorders, elevated intracranial blood pressure
  • Assumption of drugs facilitating seizures, psychiatric drugs, alcohol abuse

Key Trial Info

Start Date :

April 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2019

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT04875949

Start Date

April 1 2016

End Date

April 1 2019

Last Update

May 6 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Humanitas Research Hospital

Rozzano, Italy, 20089