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

Primary Purpose

ALS

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

rTMS

About this trial

This is an interventional treatment trial for ALS

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
1. Hormonal (oral, implanted, injected, etc)
2. Intrauterine device in place for ≥ 3 months
3. Adequate barrier method in conjunction with spermicide
4. Other
Absence of exclusion criteria.

EExclusion 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Patients who are withdrawn from the following drugs within 6 months: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

Sites / Locations

Shara Holzberg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervention

Arm Description

rTMS

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

rTMS is known to ameliorate depressive symptoms in patients with treatment resistant depression. It may also ameliorate depressive symptoms in subjects with ALS. This is measured using MQOL (Montreal Quality of life scale). This is a patient-reported instrument designed to assess overall well-being over a two day time scale. this single item scale is scored from 0-10 with higher score representing higher quality of life ratings. percent change from baseline to study completion will be measured to assess the efficacy of rtms in improving overall quality of life.

Full Information

NCT ID

NCT03373981

First Posted

November 30, 2017

Last Updated

November 9, 2022

Sponsor

Hospital for Special Surgery, New York

1. Study Identification

Unique Protocol Identification Number

NCT03373981

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Terminated

Why Stopped

Did not meet target enrollment

Study Start Date

November 29, 2017 (Actual)

Primary Completion Date

August 16, 2022 (Actual)

Study Completion Date

August 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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: Symptomatic improvement in mood, Causing a significant positive change in disease progression or Helping improve quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ALS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

open label single arm

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intervention

Arm Type

Experimental

Arm Description

rTMS

Intervention Type

Device

Intervention Name(s)

rTMS

Intervention Description

repetitive transcranial magnetic stimulation

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

over 4 weeks, done once a week

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. EExclusion 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

Facility Information:

Facility Name

Shara Holzberg

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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