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

Brief Title

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

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.
    


Study Type

Interventional


Primary Outcome

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.

Secondary Outcome

 To understand the impact of rTMS in addressing the mood symptoms associated with ALS.

Condition

ALS

Intervention

rTMS

Study Arms / Comparison Groups

 intervention
Description:  rTMS

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

15

Start Date

November 29, 2017

Completion Date

November 20, 2021

Primary Completion Date

November 20, 2021

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
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

, 2127742361, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03373981

Organization ID

2016-0326


Responsible Party

Sponsor

Study Sponsor

Hospital for Special Surgery, New York


Study Sponsor

, , 


Verification Date

January 2020