rTMS in Treatment of Spasticity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04054141|
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|ALS||Device: Mag Stim||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label rTMS treatment|
|Masking:||None (Open Label)|
|Official Title:||TMS for Treatment of Spasticity in Patients With MND|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||October 1, 2020|
Experimental: 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.
Device: Mag Stim
- 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. [ Time Frame: 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
- To evaluate efficacy of rTMS using a modified FDA approved protocol in research subjects with PLS and UMN/MND. [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054141
|Contact: Mona Shahbazi, NPfirstname.lastname@example.org|
|United States, New York|
|New York, New York, United States, 06883|
|Contact: Mona Shahbazi 212-774-2361 email@example.com|