Dystonia Treatment With Injections Supplemented By Transcranial Magnetic Stimulation — D-TWIST  

Cervical Dystonia Clinical Trial

Official title: Dystonia Treatment With Injections Supplemented By Transcranial Magnetic Stimulation

Status Completed

Clinical Trial Summary

We will apply 16 sessions of rTMS over 4 consecutive days for adult patients suffering from cervical dystonia who receive botox on a regular basis. The TMS protocol will take place 9 weeks following their last botox injection. The primary outcome measure will be improvement in cervical dystonia as measured by the TWSTRS scale. The secondary outcome measures include mood, cognition, gait, TMS measures, and high-density EEG measures.

Clinical Trial Description

This is a crossover study design in which patients will be randomized to active or sham stimulation during session 1 (S1) and then crossover to the condition they were not randomized to at first during session 2 (S1). Patients who are receiving botox for cervical dystonia on a regular basis but having benefit from botox for 9 weeks or less will be eligible to participate. The total study protocol will take place over 24 weeks. During week 1, patients will have their regularly scheduled botox injections. During week 9, patients will undergo either active or sham rTMS, as detailed below. They will have 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 will undergo their regularly scheduled botox injections. During week 21, patients will undergo either active or sham rTMS, whichever condition they were not randomized into during the first session. They will have 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 will be as follows: The dPMC target will be defined as 1 cm medial and 2 cm anterior to the site of RMT acquisition. The rTMS protocol will be as follows: each session will consist of 1-Hz rTMS over the dPMC for 30 minutes (1800 pulses) at 90% of the RMT. Patients will receive 4 sessions per day for 4 consecutive days with a 10-minute break between each session. Daily duration of the rTMS protocol, including breaks, will last approximately 160 minutes ;

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

• NCT number: NCT04916444
• Study type: Interventional
• Source: University of Florida
• Status: Completed
• Phase: N/A
• Start date: February 7, 2022
• Completion date: December 7, 2022