rTMS in Treatment of Spasticity

Not Applicable

Terminated

• Conditions: ALS
• Interventions: Device: Mag Stim

• Registration Number: NCT04054141
• Lead Sponsor: Hospital for Special Surgery, New York

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.

Study Timeline

• Study First Submitted: 2018-08-13
• Study Start: 2018-09-01
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-13
• Primary Completion: 2022-08-16
• Study Completion: 2022-08-16
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rTMS arm	Mag Stim	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.

Primary Outcome Measures

Name	Time	Method
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.	from week 0 to the end of the study, an average of 5 months.	Transcranial magnetic stimulation is a non-invasive procedure used to stimulate small regions of the brain. The effect of rTMS on spasticity was studied in patients with stroke, MS, SCI and CP and found to be safe (4). There are no studies assessing safety of rTMS in patients with PLS and UMN/ MND with spasticity. Because it is so well tolerated in other diseases, we anticipate no adverse effects. However, we will systematically assess all adverse effects with stringent stopping rules for individual patients and the study. We hypothesize that no patient will have a serious treatment related adverse event. Therefore we will track the number of Participants With Treatment-Related AE as Assessed by CTCAE v4.0

Secondary Outcome Measures

Name	Time	Method
To evaluate efficacy of rTMS using a modified FDA approved protocol in research subjects with PLS and UMN/MND.	From week 0 to end of the study, an average of 5 months	The secondary objective of this study is to determine if rTMS causes an improvement in walking speed in patients with PLS and UMN/MND. This will be determined by evaluation of subject's walking speed during treatment and for period after the rTMS stimulation series has stopped. The primary end point will be measured through the consistent improvement in the Timed 25 Foot walk test (T25FW).

Trial Locations

Locations (1)

Shara Holzberg; 🇺🇸 New York, New York, United States