Cerebellar Transcranial Direct Current Stimulation (tDCS) in Patients With Isolated Cervical Dystonia (CD)

NCT07014384 | Recruiting

• 1 other identifier: Cereb_tDCS_in_CD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical dystonia (CD) is a movement disorder characterized by involuntary muscle contractions of the neck, leading to abnormal head postures and movement, pain and impaired motor function. Current treatments for CD, such as botulinum toxin injections and physical therapy, may not always provide sufficient relief of symptoms and may fail to offer long-term benefits for patients. As a result, new therapeutic approaches are needed. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that modulates neuronal activity. Recent neurophysiological studies suggest that cerebellar tDCS (ctDCS), in particular, could be beneficial in modulating the activity of the sensorimotor network in CD. This clinical trial aims to investigate the effects of ctDCS on the excitability of the sensorimotor network and motor symptom severity in CD patients. Applying transcranial magnetic stimulation (TMS) we will evaluate the effects of anodal, cathodal and sham ctDCS to improve the understanding of the neurophysiological mechanisms underlying CD and the potential therapeutic role of ctDCS.

Conditions

Isolated Cervical Dystonia

Keywords

Isolated Cervical Dystonia; Transcranial direct current stimulation (tDCS); Transcranial magnetic stimulation (TMS); Sensorimotor network; Cerebellum; Non-invasive brain stimulation

Outcome Measures

Primary Outcomes (1)

• Changes in sensorimotor network

  Before and after each tDCS intervention, TMS will be used to assess the neurophysiological properties of the sensorimotor network with four main metrics: 1. Single-pulse TMS (SP-TMS): MEPs will be recorded from the right FDI in response to single-pulse TMS applied over the left primary motor cortex. 2. Short-interval intracortical inhibition (SICI): SICI will be assessed using a paired-pulse TMS protocol, in which two stimuli are delivered at a short interstimulus interval over the primary motor cortex. 3. Short-latency afferent inhibition (SAI): SAI consists of electrical conditioning stimuli to the right index finger preceding the test stimulus delivered by TMS to the left primary motor cortex. 4. Cerebellar-brain-inhibition (CBI): To assess CBI, a conditioning stimulus will be applied over the right cerebellar hemisphere using a second magnetic coil, followed by a cortical test stimulus over the left primary motor cortex.

  Baseline (pre-intervention) and immediately after the intervention

Secondary Outcomes (1)

• Clinical symptom severity

  Baseline (pre-intervention) and immediately after the intervention

Study Arms (3)

Anodal ctDCS

ACTIVE COMPARATOR

Patients receive anodal ctDCS stimulation for 20 minutes with 2 mA

Device: Anodal and cathodal ctDCS

Cathodal ctDCS

ACTIVE COMPARATOR

Patients receive cathodal ctDCS stimulation for 20 minutes with 2 mA

Device: Anodal and cathodal ctDCS

Sham stimulation

SHAM COMPARATOR

Patients receive ctDCS stimulation for 20 minutes with 0 mA

Device: Sham stimulation

Interventions

Anodal and cathodal ctDCS DEVICE

CtDCS will be delivered using an DC-stimulator and two saline-soaked sponge electrodes: one electrode placed 3 cm lateral to the right of the inion, the other electrode on the right buccinator muscle. A 2 mA current will be delivered through these electrodes for a duration of 20 minutes with a 8-second fade-in and fade-out.

Anodal ctDCS; Cathodal ctDCS

Sham stimulation DEVICE

The tDCS procedure will be identical to the active (anodal and cathodal) stimulation condition, but stimulation will cease after 30 seconds.

Sham stimulation

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of isolated cervical dystonia
• Written informed consent by the patient

You may not qualify if:

• History of other neurological disorders other than CD
• Secondary dystonia
• Severe head tremor
• Intake of centrally acting medication
• Contraindications to TMS, such as metallic implants, pregnancy and history of seizures

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of Neurology, University Medical Center Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Related Publications (7)

• Ugawa Y, Uesaka Y, Terao Y, Hanajima R, Kanazawa I. Magnetic stimulation over the cerebellum in humans. Ann Neurol. 1995 Jun;37(6):703-13. doi: 10.1002/ana.410370603.

  PMID: 7778843 BACKGROUND

• Porcacchia P, Alvarez de Toledo P, Rodriguez-Baena A, Martin-Rodriguez JF, Palomar FJ, Vargas-Gonzalez L, Jesus S, Koch G, Mir P. Abnormal cerebellar connectivity and plasticity in isolated cervical dystonia. PLoS One. 2019 Jan 25;14(1):e0211367. doi: 10.1371/journal.pone.0211367. eCollection 2019.

  PMID: 30682155 BACKGROUND

• Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

  PMID: 10990547 BACKGROUND

• Hamada M, Strigaro G, Murase N, Sadnicka A, Galea JM, Edwards MJ, Rothwell JC. Cerebellar modulation of human associative plasticity. J Physiol. 2012 May 15;590(10):2365-74. doi: 10.1113/jphysiol.2012.230540. Epub 2012 Apr 2.

  PMID: 22473780 BACKGROUND

• Grimm K, Prilop L, Schon G, Gelderblom M, Misselhorn J, Gerloff C, Zittel S. Cerebellar Modulation of Sensorimotor Associative Plasticity Is Impaired in Cervical Dystonia. Mov Disord. 2023 Nov;38(11):2084-2093. doi: 10.1002/mds.29586. Epub 2023 Aug 28.

  PMID: 37641392 BACKGROUND

• Brighina F, Romano M, Giglia G, Saia V, Puma A, Giglia F, Fierro B. Effects of cerebellar TMS on motor cortex of patients with focal dystonia: a preliminary report. Exp Brain Res. 2009 Feb;192(4):651-6. doi: 10.1007/s00221-008-1572-9. Epub 2008 Sep 25.

  PMID: 18815775 BACKGROUND

• Albanese A, Bhatia K, Bressman SB, Delong MR, Fahn S, Fung VS, Hallett M, Jankovic J, Jinnah HA, Klein C, Lang AE, Mink JW, Teller JK. Phenomenology and classification of dystonia: a consensus update. Mov Disord. 2013 Jun 15;28(7):863-73. doi: 10.1002/mds.25475. Epub 2013 May 6.

  PMID: 23649720 BACKGROUND

Central Study Contacts

Simone Zittel, Dr. med.

CONTACT

+49 40 7410 53770; s.zittel-dirks@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 11, 2025
• Study Start: September 15, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)