Non-invasive Brain Stimulation for the Treatment of Depression Symptoms in ALS: A Pilot Study
Study Purpose:
This is an open-label clinical trial to determine the safety of rTMS and efficacy in improving depression symptoms, quality of life and cognition deficits among patients with Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative disorders.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALSStudy Type:
Interventional TrialStudy Category:
DeviceStudy Status:
EnrollingPhase:
Not ApplicableStudy Chair(s)/Principal Investigator(s):
Clinicaltrials.gov ID (11 digit #):
NCT03373981Neals Affiliated?
NoCoordinating Center Contact Information
Hospital for Special SurgeryMona Shahbazi / .(JavaScript must be enabled to view this email address) / shahbazim@hss.edu
Shara Holzberg / .(JavaScript must be enabled to view this email address) New York, New York 10021 United States
Full Study Summary:
he objective of this study is to evaluate the role of repetitive transcranial magnetic stimulation (rTMS) for symptom reduction of depression and cognitive loss among patients with Amyotrophic Lateral Sclerosis (ALS) and other Neurodegenerative Diseases. Behavioral symptoms in ALS have been under scrutiny since its earliest descriptions, nearly 30 years ago (1). The importance of these symptoms among subjects with ALS has been also been under steady scrutiny. Studies have shown that the rates of anxiety and depression are significantly higher among subjects with ALS than the general population (1-23). Anxiety symptoms are related to depression, quality of life, and satisfaction with life (4, 9, 11, 15, 20, 24-26). Depressive symptoms are closely related to the ALS disease process (2).
rTMS has been shown to be a promising tool in modulating mood, memory, and cognitive performance (27). Current approaches to the management of ALS involve addressing symptomatology associated with the disease process. Among patients with ALS and other similar Neurodegenerative disorders, it is therefore important to understand if rTMS as an intervention is capable of:
Symptomatic improvement in mood,
Causing a significant positive change in disease progression or
Helping improve quality of life.