Health TrialsbyHealthPanel

Noninvasive Brain Stimulation for Cervical Dystonia

ConditionCervical Dystonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFondazione Policlinico Universitario Campus Bio-Medico

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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.

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: Active cTBSExperimental treatment 1 intervention
Group B: Sham cTBSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Symptoms of cervical dystonia - Toronto Western Spasmodic Torticollis Rating Scale total score

The total score on the Toronto Western Spasmodic Torticollis Rating Scale. Range: 0-85. Higher scores mean worse symptoms.

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

Secondary outcomes

1

Symptoms of cervical dystonia - Toronto Western Spasmodic Torticollis Rating Scale subscales

The scores on each of the subscales of the Toronto Western Spasmodic Torticollis Rating Scale (severity, disability, pain). Higher scores mean worse symptoms.

Time frame
For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
2

Symptoms of cervical dystonia - kinematic recordings

Metrics of patients' head and neck movements from a wearable motion sensor. Higher scores will mean greater movement error.

Time frame
For a single patient, 10 days. Pre and post cTBS
3

Motor evoked potentials

Motor evoked potential amplitudes from input-output curves, measured using surface electromyography

Time frame
For a single patient, 10 days. Pre and post cTBS
4

Magnetic resonance imaging

Functional connectivity changes from pre-defined regions of interest in the brain

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Campus Bio-Medico

Lead sponsor

European Commission

Collaborator

Source ClinicalTrials.gov
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