MedTrace Logo

Repetitive Transcranial Magnetic Stimulation as Therapy for Depression in Amyotrophic Lateral Sclerosis

NCT03892863 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-02-10

No results posted yet for this study

Summary

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterized by progressive loss of central and peripheral motor neurons. ALS leads to death usually within 3 to 5 years from the onset of the symptoms. Available treatment can prolong the disease duration but cannot modify the disease course. Depression is a frequent complication of ALS, which further decreases quality of life and the available data concerning effectivity of antidepressant drugs are conflicting. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity with confirmed antidepressive effect. The purpose of this study is to compare the effectiveness of rTMS in improving the depression in patients with ALS with placebo stimulation. Intervention will include 10 daily sessions. In each session 3000 magnetic pulses will be administered over the left dorsolateral prefrontal cortex. Assessment depression severity will be made before and after therapy, as well as two and four weeks later.

Conditions

Interventions

DEVICE

active repetitive transcranial magnetic stimulation

High frequency rTMS to induce the long term potentiation in the left dorsolateral prefrontal cortex

DEVICE

sham repetitive transcranial magnetic stimulation

High frequency rTMS to induce the long term potentiation in the left dorsolateral prefrontal cortex

Sponsors & Collaborators

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Jakub M Antczak, MD · Department of Neurology, Jagiellonian University Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2021-06-30
Completion
2021-12-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03892863 on ClinicalTrials.gov