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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 ALS

Study Type:

Interventional Trial

Study Category:

Device

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Clinicaltrials.gov ID (11 digit #):

NCT03373981

Neals Affiliated?

No

Coordinating Center Contact Information

Hospital for Special Surgery
Mona 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.

Study Sponsor:

Hospital for Special Surgery, New York

Participant Duration:

Estimated Enrollment:

15

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
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    99

    Time since Symptom Onset:

    Time since Diagnosis:

    <24 months

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    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.
    MMSE ≥20

    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
    • Other

    Absence of exclusion criteria.

    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:

    • Barbiturates
    • Benzodiazepines
    • Meprobamate
    • Chloral hydrate

    Patients who have a recent history (within 24h) or chronic history of intake of:

    Cocaine.
    Phencyclidine Phosphate.
    Gamma-Hydroxy Butyrate.

    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

  • Site Contact Information

    Hospital for Special Surgery
    Mona Shahbazi / .(JavaScript must be enabled to view this email address) / New York, New York 10021
    United States