Non-invasive Brain Stimulation for the Treatment of Depression Symptoms in ALS

Conditions:Depression, ALS
Therapuetic Areas:Psychiatry / Psychology, Other
Age Range:18 - 99
Start Date:November 29, 2017
End Date:November 20, 2019
Contact:Mona Shahbazi

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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.

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.

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

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
We found this trial at
535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
New York, NY
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