Non-invasive Brain Stimulation for the Treatment of Depression Symptoms in ALS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03373981|
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : February 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|ALS||Device: rTMS||Not Applicable|
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:
- Symptomatic improvement in mood,
- Causing a significant positive change in disease progression or
- Helping improve quality of life.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open label single arm|
|Masking:||None (Open Label)|
|Official Title:||Non-invasive Brain Stimulation for the Treatment of Depression Symptoms in ALS: A Pilot Study|
|Actual Study Start Date :||November 29, 2017|
|Estimated Primary Completion Date :||November 20, 2021|
|Estimated Study Completion Date :||November 20, 2021|
repetitive transcranial magnetic stimulation
- To evaluate safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) using the FDA approved protocol in research subjects with ALS and other Neurodegenerative disorders. [ Time Frame: over 4 weeks, done once a week ]Transcranial magnetic stimulation (TMS) is a non-invasive procedure used to stimulate small regions of the brain. It is a FDA approved for treatment resistant depression (K061053). We hypothesize that stimulation of dorsolateral prefrontal cortex (DLPFC) will be safe and effective in patients with ALS and other Neurodegenerative disorders. We will follow the FDA rTMS guidance for industry guidelines. All adverse events from all 15 patients enrolled in the study as assessed by the CTCAE v4.0, and as well, any occurrence of any new seizure in 2 or more patients, as reviewed and assessed by PI and medical monitor.
- To understand the impact of rTMS in addressing the mood symptoms associated with ALS. [ Time Frame: recorded once a week for the 4 week duration of the study. ]rTMS is known to ameliorate depressive symptoms in patients with treatment resistant depression. It may also ameliorate depressive symptoms in subjects with ALS. This is measured using MQOL (Montreal Quality of life scale). This is a patient-reported instrument designed to assess overall well-being over a two day time scale. this single item scale is scored from 0-10 with higher score representing higher quality of life ratings. percent change from baseline to study completion will be measured to assess the efficacy of rtms in improving overall quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373981
|Contact: Mona Shahbazifirstname.lastname@example.org|
|Contact: Shara Holzbergemail@example.com|
|United States, New York|
|Hospital for Special Surgery||Recruiting|
|New York, New York, United States, 10021|
|Contact: Mona Shahbazi firstname.lastname@example.org|