Clinical trial NCT03373981: Non-invasive Brain Stimulation for the Treatment of Depression Symptoms in ALS
Official title: Non-invasive Brain Stimulation for the Treatment of Depression Symptoms in ALS: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ALS
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label single arm
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

EExclusion Criteria

1. Unable to provide informed consent
2. Significant speech impairment
3. Inability to comply with the procedures
4. Subjects with ALS diagnosis ≥ 2 years
5. Inability to communicate clearly if the subject wants to withdraw from the procedure at any stage
6. Seizures or history of seizures
7. Patients who have underwent brain surgery for any indication
8. Patients with pacemakers, cochlear implants, brain stimulators, infusion pumps, intracardiac lines, metallic clips, other implanted electronic or ferroelectric metallic devices. Dental implants are permitted
9. Inability to perform either TMS or NCS studies due to insufficient MEP or CMAP amplitude.
10. Patients with uncontrolled hypertension
11. Patients with neuro endocrine disorders
12. 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

Primary outcomes:
measure: 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.
timeFrame: over 4 weeks, done once a week
Secondary outcomes:
measure: To understand the impact of rTMS in addressing the mood symptoms associated with ALS.
timeFrame: recorded once a week for the 4 week duration of the study.
Other outcomes:
Locations:
city: New York
country: United States
facility: Shara Holzberg
state: New York
Study officials:
References: