Noninvasive Brain Stimulation for Cervical Dystonia

NCT07681284 | Not Yet Recruiting

• 1 other identifier: NetworkStim 270.25 CET2 cbm
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to assess whether continuous theta-burst stimulation (cTBS) can be helpful in reducing symptoms of idiopathic cervical dystonia. This will be a parallel-group, randomised, sham-controlled, double blind clinical trial. Patients and investigators measuring patient symptoms clinical scales will be blinded from allocation group, investigators delivering the intervention will not be blinded, as this is not feasible. Real cTBS will be compared to sham cTBS, with patients allocated to these two groups with a 1:1 recruitment ratio. Bilateral cTBS will be delivered four times daily, over eight days, for a total of 32 bilateral cTBS sessions. The primary outcome is the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). This will be administered at T1 (pre-cTBS), T2 (day 10, following days 2-9 where patients received the intervention), T3 (2 weeks post the final session of cTBS), and T4 (4-5 weeks post the final session of cTBS). Secondary outcomes will be the TWSTRS subscales (severity, disability, pain), Quality of Life scale, Global dystonia severity rating scale (GDS), Fahn Tolosa Marin (FTM) modified (to include only questions relevant to head/neck tremor) tremor scale, kinematic data of patient's movement patterns, motor evoked potentials (MEPs), and resting-state fMRI data (fMRI).

Conditions

Cervical Dystonia

Keywords

Cervical dystonia; Transcranial magnetic stimulation; Somatosensory cortex; Continuous theta-burst stimulation

Outcome Measures

Primary Outcomes (1)

• Symptoms of cervical dystonia - TWSTRS total score

  The total score on the Toronto Western Spasmodic Torticollis Rating Scale

  For a single patient, a minimum of 6 weeks and a maximum of 16 weeks

Secondary Outcomes (6)

• Symptoms of cervical dystonia - TWSTRS subscales

  For a single patient, a minimum of 6 weeks and a maximum of 16 weeks

• Symptoms of cervical dystonia - kinematic recordings

  For a single patient, 10 days. Pre and post cTBS

• Motor evoked potentials

  For a single patient, 10 days. Pre and post cTBS

• Magnetic resonance imaging

  For a single patient, 10 days. Pre and post cTBS

• Fahn Tolosa Marin tremor scale

  For a single patient, a minimum of 6 weeks and a maximum of 16 weeks

Study Arms (2)

Active cTBS

EXPERIMENTAL

The patients of this group will receive 4 sessions of bilateral somatosensory cortex cTBS per day for 8 days

Device: Active continuous theta-burst stimulation

Sham cTBS

SHAM COMPARATOR

The patients of this group will receive 4 sessions of bilateral somatosensory cortex cTBS per day for 8 days, delivered using a sham TMS coil.

Device: Sham continuous theta-burst stimulation

Interventions

Active continuous theta-burst stimulation DEVICE

Continuous theta-burst stimulation (cTBS) will be delivered using a Magstim Rapid machine connected to a 70mm cooled coil at 80% of a participants resting motor threshold (RMT). cTBS will consist of three-pulse bursts at 50Hz repeated every 200ms (5Hz) for 40 seconds (600 pulses total) (Huang, Edwards et al. 2005). All cTBS procedures will be conducted bilaterally, with application first over the left hemisphere, before moving to the right (approximately one minute will separate each hemisphere). Bilateral cTBS will be delivered four times daily, over eight days, for a total of 32 bilateral cTBS sessions. This 4x day protocol will follow prior studies in neglect patients, delivered at time intervals of 0, 15, 60, and 75 minutes (Nyffeler, Cazzoli et al. 2008, Cazzoli, Müri et al. 2012, Nyffeler, Vanbellingen et al. 2019).

Active cTBS

Sham continuous theta-burst stimulation DEVICE

Sham cTBS procedures will be identical to those in the active cTBS arm but applied using a 70mm sham TMS coil.

Sham cTBS

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead
• European Commission: collaborator

Study Sites (1)

Università Campus Bio-Medico

Roma, Roma, 00128, Italy

Location

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

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

Study Officials

• Vincenzo Di Lazzaro, MD

  Campus Bio-Medico Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel T Corp, PhD

CONTACT

+393445660971; danieltcorp@gmail.com

Ambra Salvati

CONTACT

+393491028595; ambra.salvati@unicampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors are blinded to treatment allocation. The investigators administering cTBS are not blinded due to the nature of the intervention but are not involved in outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): May 6, 2028
• Study Completion (Estimated): May 6, 2028
• Last Updated: July 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The Study Protocol, SAP, and ICF will be made available with this pre-registration prior to study commencement. Generated participant data and code will be available after the pre-print of the publication describing it are released. There is no time limit for how long the data will be made available.
• Access Criteria: Public access as per the terms of clinicaltrials.gov and the OpenNeuro and Big NIBS data repositories.

Locations

IT (1)