ALS
Conditions
Brief 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.
Interventions
DEVICErTMS
repetitive transcranial magnetic stimulation
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open label single arm
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of familial or sporadic ALS as well as other Neurodegenerative disorders. Verification of the diagnosis will be performed by the Principal Investigator. This diagnosis can include neuro-degenerative disorders of uncertain cause, including ALS, MND, Peripheral neuropathies, Parkinson's and other progressive motor system diseases. 2. If subjects has ALS diagnosis, the date of dx should be ≤ 2 years 3. Age 18 or older. 4. Capable of providing informed consent. 5. Minimal speech impairment. 6. Ability to comply with study procedures. 7. Ability to communicate clearly if the subject wants to withdraw from the procedure at any stage. 8. MMSE ≥20 9. Female subjects of child bearing potential must engage in abstinence for the duration of the study. If a participant becomes sexually active, she must agree to using the following birth control methods: 1. Hormonal (oral, implanted, injected, etc) 2. Intrauterine device in place for ≥ 3 months 3. Adequate barrier method in conjunction with spermicide 4. Other 10. Absence of
Exclusion criteria
. E
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To understand the impact of rTMS in addressing the mood symptoms associated with ALS. | 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. |
Countries
United States
Outcome results
None listed