Non-invasive Brain Stimulation for the Treatment of Depression Symptoms in ALS: A Pilot Study
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 ALS
Study Type:Interventional Trial
Study Chair(s)/Principal Investigator(s):
Clinicaltrials.gov ID (11 digit #):NCT03373981
Coordinating Center Contact InformationHospital for Special Surgery
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.
Study Sponsor:Hospital for Special Surgery, New York
Estimated Study Start Date:11/29/2017
Estimated Study Completion Date:11/20/2019
Posting Last Modified Date:05/15/2019
Date Study Added to alsconsortium.org:05/15/2019
Time since Symptom Onset:
Time since Diagnosis:<24 months
Can participants use Riluzole?Yes
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.
If subjects has ALS diagnosis, the date of dx should be ≤ 2 years
Age 18 or older.
Capable of providing informed consent.
Minimal speech impairment.
Ability to comply with study procedures.
Ability to communicate clearly if the subject wants to withdraw from the procedure at any stage.
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:
- Hormonal (oral, implanted, injected, etc)
- Intrauterine device in place for ≥ 3 months
- Adequate barrier method in conjunction with spermicide
Absence of exclusion criteria.
Unable to provide informed consent
Significant speech impairment
Inability to comply with the procedures
Subjects with ALS diagnosis ≥ 2 years
Inability to communicate clearly if the subject wants to withdraw from the procedure at any stage
Seizures or history of seizures
Patients who have underwent brain surgery for any indication
Patients with pacemakers, cochlear implants, brain stimulators, infusion pumps, intracardiac lines, metallic clips, other implanted electronic or ferroelectric metallic devices. Dental implants are permitted
Inability to perform either TMS or NCS studies due to insufficient MEP or CMAP amplitude.
Patients with uncontrolled hypertension
Patients with neuro endocrine disorders
Patients who are withdrawn from the following drugs within 6 months:
- Chloral hydrate
Patients who have a recent history (within 24h) or chronic history of intake of:
Amphetamines including N-methylamphetamine, 3,4-Methylenedioxymethamphetamine, 2,5-dimethoxy-4-methylamphetamine, Ephedrine, Cathinone.
12. Substance abuse+ 13. Excessive use of alcohol # 14. MMSE ≤19 15. Female patients of child bearing potential not practicing contraception 16. Female patients who are pregnant
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