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rTMS in Treatment of Spasticity

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ClinicalTrials.gov Identifier: NCT04054141
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Tracking Information
First Submitted Date  ICMJE August 13, 2018
First Posted Date  ICMJE August 13, 2019
Last Update Posted Date October 5, 2021
Actual Study Start Date  ICMJE September 1, 2018
Estimated Primary Completion Date October 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2019)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE rTMS in Treatment of Spasticity
Official Title  ICMJE TMS for Treatment of Spasticity in Patients With MND
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open label rTMS treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE ALS
Intervention  ICMJE Device: Mag Stim
rTMS
Study Arms  ICMJE 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.

Intervention: Device: Mag Stim
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 9, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2024
Estimated Primary Completion Date October 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mona Shahbazi, NP 6467978917 shahbazim@hss.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04054141
Other Study ID Numbers  ICMJE 2018-0434
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital for Special Surgery, New York
Study Sponsor  ICMJE Hospital for Special Surgery, New York
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital for Special Surgery, New York
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP