Dystonia Treatment With Injections Supplemented By Transcranial Magnetic Stimulation

NCT ID: NCT04916444

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2024-01-07

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.

Detailed Description

This was a crossover study design in which patients were randomized to active or sham stimulation during session 1 (S1) and then crossed over to the condition they were not randomized to at first during session 2 (S1). Patients who were receiving BoNT injections for cervical dystonia on a regular basis but only noted benefit from BoNT for 9 weeks or less were eligible to participate. The total study protocol took place over 24 weeks. During week 1, patients had their regularly scheduled botox injections. During week 9, patients underwent either active or sham rTMS, as detailed below. They had outcome measures obtained at week 9 (S1:T0; baseline/pre-TMS), week 10 (S1:T1; post-TMS), and week 12 (S1:T2; 2 weeks post-TMS). At week 12, they underwent their regularly scheduled BoNT injections. During week 21, patients underwent either active or sham rTMS, whichever condition they were not randomized into during the first session. They then had outcome measures obtained at week 21 (S2:T0; baseline/pre-TMS), week 22 (S2:T1; post-TMS), and week 24 (S2:T2; 2 weeks post-TMS).

The neurostimulation protocol was as follows: The dPMC target was defined as 1 cm medial and 2 cm anterior to the site of RMT acquisition. The rTMS protocol was as follows: each session consisted of 1-Hz rTMS over the dPMC for 30 minutes (1800 pulses) at 90% of the RMT. Patients received 4 sessions per day for 4 consecutive days with a 10-minute break between each session. The daily duration of the rTMS protocol, including breaks, lasted approximately 160 minutes.

Conditions

Cervical Dystonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active rTMS

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

Group Type: ACTIVE_COMPARATOR

rTMS

Intervention Type: 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.

Sham rTMS

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.

Group Type: SHAM_COMPARATOR

rTMS

Intervention Type: 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.

Interventions

rTMS

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.

Intervention Type: DEVICE

Other Intervention Names

Transcranial Magnetic Stimulation

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dystonia Medical Research Foundation

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Yu, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida Health Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

OCR40846

Identifier Type: OTHER

Identifier Source: secondary_id

IRB202101156

Identifier Type: -

Identifier Source: org_study_id