rTMS in Treatment of Spasticity

NCT04054141 | Terminated FDA Device

• 1 other identifier: 2018-0434
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

ALS

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  from week 0 to the end of the study, an average of 5 months.

Secondary Outcomes (1)

• 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

Study Arms (1)

rTMS arm

EXPERIMENTAL

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

Interventions

Mag Stim DEVICE

rTMS

rTMS arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Shara Holzberg

New York, New York, 10021, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label rTMS treatment

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 13, 2019
• Study Start: September 1, 2018
• Primary Completion: August 16, 2022
• Study Completion: August 16, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

US (1)