Noninvasive brain stimulation for cervical dystonia using continuous theta-burst in a sham-controlled trial

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this parallel-group, randomized, double-blind trial, participants with idiopathic cervical dystonia will receive bilateral continuous theta-burst stimulation or sham stimulation over eight days (32 sessions total). The primary outcome is change in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline to several follow-up points. Outcomes are assessed by investigators who are blinded to treatment, with the interventionists not blinded due to feasibility. The study builds on prior work exploring functional brain networks linked to cervical dystonia.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Aged between 18 and 85 years
* Diagnosis of idiopathic cervical dystonia made by an expert physician
* Last botulinum toxin injection administered at least two months before the start of participation in the study (Albanese, Abbruzzese et al. 2015)

Exclusion Criteria

* Head or neck trauma occurring less than 12 months before the onset of dystonia
* Acquired dystonia (e.g., drug-induced, brain lesions or trauma)
* History of major psychiatric disorders (e.g., bipolar disorder, schizophrenia, obsessive-compulsive disorder)
* History of neurological diseases other than CD (e.g., epilepsy, Parkinson's disease)
* Other contraindications for TMS or brain MRI (e.g., metal in the head)
* Pregnant or breastfeeding women
* History of substance abuse or dependence

Where it's running

• Università Campus Bio-Medico
  Roma, Roma, Italy Recruiting

Study contacts

• Principal investigator: Vincenzo Di Lazzaro, MD — Campus Bio-Medico Hospital
• Study coordinator: Daniel T Corp, PhD
• Email: danieltcorp@gmail.com
• Phone: +393445660971

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Targeted Focused Ultrasound for Cervical Dystonia

  This trial tests whether applying theta burst focused ultrasound to brain regions GPi or DN, or a sham, can help people with cervical dystonia.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT07690514

• Vibration to improve head posture in cervical dystonia

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• Adding zinc to Botox for cervical dystonia

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  Recruiting Phase 2 University of Florida · Gainesville, Florida · NCT07140874

• IPN10200 treatment for cervical dystonia in adults

  This trial will test whether a single injection of IPN10200 (one of two doses) reduces neck posture problems, pain, and disability better than placebo in adults with cervical dystonia.

  Recruiting at 27 sites Phase 2 Ipsen · Tucson, Arizona and 44 other locations · NCT06937931

• Using Valbenazine with Botulinum Toxin for Cervical Dystonia

  This study is testing if adding a medication called valbenazine to botulinum toxin injections can help people with cervical dystonia feel better and improve their quality of life.

  Recruiting Phase 2 Virginia Commonwealth University · Richmond, Virginia · NCT06771323

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.