Status:
TERMINATED
Non-invasive Brain Stimulation for the Treatment of Depression Symptoms in ALS
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
ALS
Eligibility:
All Genders
18-99 years
Phase:
NA
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 Scler...
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 Latera...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03373981
Start Date
November 29 2017
End Date
August 16 2022
Last Update
November 14 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shara Holzberg
New York, New York, United States, 10021