NCT03373981

Non-invasive Brain Stimulation for the Treatment of Depression Symptoms in ALS

Non-invasive Brain Stimulation for the Treatment of Depression Symptoms in ALS: A Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The 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: 1. Symptomatic improvement in mood, 2. Causing a significant positive change in disease progression or 3. Helping improve quality of life.

Conditions

• ALS

Interventions

Type	Name	Description
DEVICE	rTMS	repetitive transcranial magnetic stimulation

Timeline

• Start date: 2017-11-29
• Primary completion: 2022-08-16
• Completion: 2022-08-16
• First posted: 2017-12-14
• Last updated: 2022-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study