ALSNCT03373981
Non-invasive Brain Stimulation for the Treatment of Depression Symptoms in ALS
A study testing rTMS in people with ALS, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- ALS
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 16 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
repetitive transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | rTMS Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: over 4 weeks, done once a week
Secondary outcomes (1)
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.
Measured: recorded once a week for the 4 week duration of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start29 Nov 2017
- Primary completion16 Aug 2022
- Study completion16 Aug 2022
Why it stopped: Did not meet target enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open label single arm
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373981
- Sponsor's protocol ID
- 2016-0326
- Status last verified
- Nov 2022
- First submitted
- 30 Nov 2017
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Brain Stimulation for the Treatment of Depression Symptoms in ALS: A Pilot Study
- ClinicalTrials.gov ID
- NCT03373981
- Acronym / sponsor ID
- 2016-0326
- Conditions
- ALS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not meet target enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label single arm
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: rTMSrTMS |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSrepetitive transcranial magnetic stimulation | Device | intervention |
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.
Time frame: over 4 weeks, done once a week
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.
1 secondary outcome
To understand the impact of rTMS in addressing the mood symptoms associated with ALS.
Time frame: recorded once a week for the 4 week duration of the study.
Results and safety
The study was stopped early (reason given: Did not meet target enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with ALS, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Did not meet target enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: over 4 weeks, done once a week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.