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

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.

• 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