rTMS in Treatment of Spasticity

NCT ID: NCT04054141

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2022-08-16

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.

Conditions

ALS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rTMS arm

Each patient's participation will last a maximum of 12 weeks and involves 2 sessions of neurophysiological testing (TMS) sessions and 15 neurophysiological treatment sessions (rTMS).

Patients will have a neurophysiological testing session (TMS) at the screening visit (week 0). Patients will then return for 15 neurophysiological treatment sessions (rTMS) within 14 days of screening. Patients must complete three neurophysiological treatment sessions (rTMS) during weeks 1, 2, 3, 4 and 5. The second neurophysiological testing session will be done at the final visit (week 5). Follow-up visits will be scheduled at weeks 7 and 10 (+/- 3 days). That is, the follow-up visits will occur two and five weeks after the final rTMS session which occurs on day 15.

Group Type: EXPERIMENTAL

Mag Stim

Intervention Type: DEVICE

rTMS

Interventions

Mag Stim

rTMS

Intervention Type: DEVICE

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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shara Holzberg

New York, New York, United States

Countries

United States

Other Identifiers

2018-0434

Identifier Type: -

Identifier Source: org_study_id