Dystonia Treatment With Injections Supplemented By Transcranial Magnetic Stimulation

NCT04916444 | Completed Results DMC FDA Device

• 2 other identifiers: IRB202101156OCR40846
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

We applied 16 sessions of rTMS over 4 consecutive days for adult patients suffering from cervical dystonia who received botulinum toxin (BoNT) injections on a regular basis. The TMS protocol took place 9 weeks following their last BoNT injection. The primary outcome measure was improvement in cervical dystonia as measured by the TWSTRS scale. The secondary outcome measures included mood, cognition, and gait measures.

Conditions

Cervical Dystonia

Keywords

rTMS; cervical dystonia; botulinum toxin

Outcome Measures

Primary Outcomes (1)

• Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

  This is an objective scale evaluating patients on a variety of features including maximal excursion, duration, effects of sensory trick, shoulder elevation, range of motion, and time. Scores range from 0 to 85 where a higher score indicates more severity.

  Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)

Secondary Outcomes (5)

• Beck Depression Inventory (BDI)

  Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)

• Trail-Making Test: Part A

  Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)

• Trail-Making Test: Part B

  Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)

• Wisconsin Card Sorting Task (WCST) - %Total Errors

  Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)

• Wisconsin Card Sorting Task (WCST) - %Perseverative Errors

  Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

Active rTMS will use a figure of eight TMS coil that will deliver real neurostimulation pulses to the patients.

Device: rTMS

Sham rTMS

SHAM COMPARATOR

Sham rTMS will use a sham figure of eight TMS coil that sounds and looks like a real rTMS coil, except no neurostimulation is being delivered to the patient.

Device: rTMS

Interventions

rTMS DEVICE

repetitive transcranial magnetic stimulation is a painless, noninvasive form of neurostimulation. This study uses an accelerated protocol in which the neurostimulation pulses are delivered in 4 sessions per day over 4 consecutive days (16 total sessions). Active or sham rTMS will be provided at 9 weeks following botox injections.

Also known as: Transcranial Magnetic Stimulation

Active rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients 18-85 years of age who receive regular botulinum toxin (BoNT) scheduled every 12 weeks, on stable optimized doses but with reported benefits lasting ≤ 9 weeks for 2 consecutive cycles. Patents followed at our center routinely fill out a self-reported form to document the duration of benefits perceived with BoNT therapy. Participants will be allowed to continue oral medications that they are taking for dystonia concurrently but will not be allowed to change their concurrent medication regimen throughout the duration of the study.

You may not qualify if:

• Presence of metallic objects or neurostimulators in the brain
• Pregnancy
• History of active seizures or epilepsy
• Patients with severe scoliosis or other gait impairment that will preclude them from participating in gait evaluation.

Sponsors & Collaborators

• University of Florida: lead
• Dystonia Medical Research Foundation: collaborator

Study Sites (1)

University of Florida Health Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Torticollis

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Jun Yu
• Organization: University of Florida Norman Fixel Institute for Neurological Diseases

jun.yu@neurology.ufl.edu

352-294-5400

Study Officials

• Jun Yu, MD, MS

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A sham coil was used for sham rTMS. Both conditions underwent the exact same study procedures except the sham coil did not deliver pulses; it did still deliver a sound and tapping sensation meant to mimic the real rTMS coil, but no real stimulation was provided in this condition. Patients and outcomes assessors were not made aware of the condition that the participant was partaking in.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients were randomized to one of two conditions during session 1: active or sham rTMS. During session 2, patients underwent whichever condition they did not undergo in session 1.

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 7, 2021
• Study Start: February 7, 2022
• Primary Completion: December 20, 2023
• Study Completion: January 7, 2024
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)