Clinical trial NCT04054141: rTMS in Treatment of Spasticity
Official title: TMS for Treatment of Spasticity in Patients With MND
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ALS
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label rTMS treatment
Primary purpose: TREATMENT

Brief summary: This is an open-label clinical trial to determine the safety and efficacy of rTMS in reducing spasticity and improving quality of life among patients with upper motor neuron predominant motor neuron disease (MND).

Detailed description: The study's objective is to evaluate the role of rTMS for symptom reduction of spasticity among patients with upper motor neuron predominant motor neuron disease. This study is 12-week open label safety and efficacy trial. A total of 10 subjects with PLS and UMN/ MND will be enrolled in this study.

Eligibility criteria: Inclusion Criteria

* Age ≥ 18, men or woman
* Diagnosis of upper motor neuron predominant ALS, which also includes patients with primary lateral sclerosis (PLS), as defined as only upper motor neuron features in at least 2 body segments.
* EMG within 3 months of enrollment with minimal or no evidence of lower motor neuron disease.
* Time from symptom onset \> 18 months
* On a stable dose of, or has not taken, Riluzole for at least thirty days.
* Has not taken, or has received at least 2 cycles of dosing of, Edaravone prior to screening.
* Able to communicate clearly the desire to withdraw from the procedure at any stage.
* Impaired walking as measured by a Hauser Ambulation index of greater than 1 and less than 7 (2 to 6, inclusive).
* MMSE ≥ 22 and deemed by the PI as being capable of providing informed consent and following trial procedure.
* Has spasticity, equal or above 1 in the Ashworth Scale for spasticity in 2 or more muscle group of at least 3 months duration.
* Absence of exclusion criteria.

Exclusion criteria

* Patient has a history of drug or alcohol abuse within the past year;
* Patient has clinically significant abnormal laboratory values.
* Any concomitant disease or disorder that has spasticity-like symptoms or that may influence the subject's level of spasticity
* Received Botulinum Toxin during the preceding 6 months
* Bedridden and patients with tracheostomy.
* Fixed-tendon contractures
* Poorly controlled epilepsy or recurrent seizures (Subjects who have had one or more seizures in the year prior to Visit 1 will be excluded)
* Unable to provide an informed consent
* Unable to comply with the procedures
* Unable to communicate clearly if the subject wants to withdraw from the procedure at any stage
* History of brain surgery for any indication
* Has pacemaker, cochlear implants, brain stimulators, infusion pumps, intracardiac lines, metallic clips, other implanted electronic or ferroelectric metallic devices above the neck (Dental implants are permitted), piercing or body modification above the neck, known history of TMS related complications or side effects.
* MMSE \<22.
* Female patients of child bearing period who are not practicing contraception.
* Female patients who are pregnant.
* Inability to perform either rTMS due to insufficient MEP amplitude (\< 50 µv).

Primary outcomes:
measure: safety of rTMS in subjects with PLS/UMN/MND. Number of participants with treatment related AE's will be measured with stringent stopping rules and reported. We hypothesize that no serious treatment related adverse event.
timeFrame: from week 0 to the end of the study, an average of 5 months.
Secondary outcomes:
measure: To evaluate efficacy of rTMS using a modified FDA approved protocol in research subjects with PLS and UMN/MND.
timeFrame: From week 0 to end of the study, an average of 5 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Shara Holzberg
state: New York
Study officials:
References: