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

NCT03373981 | Terminated FDA Device

• 1 other identifier: 2016-0326
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

ALS

Outcome Measures

Primary Outcomes (1)

• 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.

  Transcranial magnetic stimulation (TMS) is a non-invasive procedure used to stimulate small regions of the brain. It is a FDA approved for treatment resistant depression (K061053). We hypothesize that stimulation of dorsolateral prefrontal cortex (DLPFC) will be safe and effective in patients with ALS and other Neurodegenerative disorders. We will follow the FDA rTMS guidance for industry guidelines. All adverse events from all 15 patients enrolled in the study as assessed by the CTCAE v4.0, and as well, any occurrence of any new seizure in 2 or more patients, as reviewed and assessed by PI and medical monitor.

  over 4 weeks, done once a week

Secondary Outcomes (1)

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

  recorded once a week for the 4 week duration of the study.

Study Arms (1)

intervention

EXPERIMENTAL

rTMS

Device: rTMS

Interventions

rTMS DEVICE

repetitive transcranial magnetic stimulation

intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Shara Holzberg

New York, New York, 10021, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open label single arm

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 14, 2017
• Study Start: November 29, 2017
• Primary Completion: August 16, 2022
• Study Completion: August 16, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

US (1)