ALS
Conditions
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.
Interventions
DEVICEMag Stim
rTMS
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label rTMS treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed