Amyotrophic Lateral Sclerosis, Plasmapheresis
Conditions
Brief summary
Patient with amyotrophic lateral sclerosis (ALS) having anti-NRIP autoantibody showed titer-dependent detrimental Effects. Plasmapheresis might benefit this subgroup of patients via removal of anti-NRIP autoantibody
Interventions
PROCEDUREPlasmapheresis
Regular plasmapheresis to remove anti-NRIP autoantibody
Sponsors
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with amyotrophic lateral sclerosis (ALS) at the age more than 20 years and having plasma anti-NRIP autoantibody. 2. Agree to receive plasmapheresis intervention. 3. Agree to participate in the trial and receive serial examinations and follow up.
Exclusion criteria
1. Patients without plasma anti-NRIP autoantibody. 2. Patients requiring permanent ventilator support for ALS progression. 3. Not able to receive plasmapheresis or trial-related examinations. 4. Under pregnancy. 5. Blood fibrinogen level less than 50 mg/dl. 6. Specific ALS subtypes, including primary lateral sclerosis, progressive muscular atrophy, flail arm syndrome, or flail leg syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ALSFRS-R decline | Before (3-month) and after (3-month) intervention | Change in ALSFRS-R decline before (3-month) and after (3-month) intervention. \<ALSFRS-R indicates revised ALS functional rating scale, ranged from 0 to 48 with the higher, the better motor function\> |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ALSFRS-R decline | Before (3-month) and after (6-month) intervention | Change in ALSFRS-R decline before (3-month) and after (6-month) intervention |
| Changes in ALSFRS-R score | Day 0 to days 30, 90, and 180 | Changes in ALSFRS-R score from day 0 to days 30, 90, and 180 |
| Change in force vital capacity | Before intervention and on day 90 | Change in force vital capacity before intervention and on day 90 |
| Change in compound motor action potentials | Before intervention and on day 90 | Change in compound motor action potentials before intervention and on day 90 |
| Changes in anti-NRIP titer | Day 0 to days 30, 90, and 180 | Changes in anti-NRIP titer from day 0 to days 30, 90, and 180 |
| Any adverse effect under plasmapheresis | Within 6 months during and after plasmapheresis | Any adverse effect during and within 6 months after plasmapheresis |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORLi-Kai Tsai, MD, PhD
National Taiwan University Hospital
Outcome results
None listed