Isolated Cervical DystoniaNCT07014384
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Patients With Isolated Cervical Dystonia (CD)
A study testing Anodal and cathodal ctDCS in people with Isolated Cervical Dystonia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Isolated Cervical Dystonia
- What is being tested?
- Anodal and cathodal ctDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 15 Sep 2024to 6 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of isolated cervical dystonia
- Written informed consent by the patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, University Medical Center Hamburg-Eppendorf
Hamburg
About this study
Official title: A Randomized, Sham-controlled Study of Cerebellar Transcranial Direct Current Stimulation (tDCS) and Its Effects on the Neurophysiological Properties of the Sensorimotor Network and Motor Symptom Severity in Patients With Isolated Cervical Dystonia (CD)
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.
Read the detailed description
Dystonia is a movement disorder characterized by involuntary, sustained or intermittent muscle contractions, resulting in abnormal movements and postures. CD is the most common form of focal dystonia. It is characterized by abnormal postures or movements of the head. Standard treatment in patients with CD includes regular botulinum toxin injections and physical therapy, but many patients continue to experience symptoms, especially towards the end of the treatment cycle, highlighting the need for alternative treatment options.
One of the challenges in treating CD is the incomplete understanding of its underlying neurophysiological mechanisms. Recently, CD has been recognized as a network disorder, affecting the basal ganglia, the brainstem, the sensorimotor cortex and the cerebellum. So far, there is increasing evidence supporting the role of the cerebellum in the pathophysiology of dystonia, including animal models, neuroimaging and neurophysiological studies, but the exact the role in the proposed dystonia network is only incompletely understood.
TDCS is a form of non-invasive brain stimulation modulating the excitability of superficially located neurons. CtDCS is known to modulate the excitability of neurons of the cerebellar cortex, while the cerebellar nuclei and the brain stem remain unaffected. It has been shown that anodal ctDCS increases and cathodal ctDCS decreases the excitability of the cerebellum.
This randomized and sham-controlled clinical trial aims to investigate the effects of anodal and cathodal ctDCS in CD patients, focusing on both the sensorimotor network excitability and motor symptom severity. Participants will undergo three separated experimental sessions separated by one week, each with a different stimulation condition: anodal, cathodal, and sham ctDCS. Both, the study participants and the experimenter will be blinded to the order of stimulation mode.
The outcome measures will include:
- Changes in the sensorimotor network before and after ctDCS stimulation, assessed by TMS. Measurements include four main metrics to determine the neurophysiological properties of the sensorimotor network in different ways:
- Single-pulse TMS (SP-TMS) of the left primary motor cortex, used to quantify the amplitude of motor-evoked potentials (MEPs) in response to unconditioned stimuli,
- Short-interval intracortical inhibition (SICI),
- Short-latency afferent inhibition (SAI),
- Cerebellar brain inhibition (CBI).
- Clinical motor symptom severity, assessed with the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) before and after each session.
This study aims to improve the understanding of the neurophysiological mechanisms and clinical effects of ctDCS in isolated CD.
- Conditions
- Isolated Cervical Dystonia
- Being tested
- Anodal and cathodal ctDCS, Sham stimulation
- Keywords
- Isolated Cervical Dystonia, Transcranial direct current stimulation (tDCS), Transcranial magnetic stimulation (TMS), Sensorimotor network, Cerebellum, Non-invasive brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal and cathodal ctDCSDevice
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.
Sham stimulationDevice
The tDCS procedure will be identical to the active (anodal and cathodal) stimulation condition, but stimulation will cease after 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Anodal ctDCS | Active comparator | Patients receive anodal ctDCS stimulation for 20 minutes with 2 mA Receives: Device: Anodal and cathodal ctDCS |
| Cathodal ctDCS | Active comparator | Patients receive cathodal ctDCS stimulation for 20 minutes with 2 mA Receives: Device: Anodal and cathodal ctDCS |
| Sham stimulation | Sham comparator | Patients receive ctDCS stimulation for 20 minutes with 0 mA Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
- 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.
- 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.
- 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.
Measured: Baseline (pre-intervention) and immediately after the intervention
Secondary outcomes (1)
Clinical symptom severity
Each session will begin and end with a clinical evaluation using the TWSTRS to quantify motor symptom severity, disability and pain associated with CD.
Measured: Baseline (pre-intervention) and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start15 Sep 2024
- Primary completion15 Sep 2025
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Isolated Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Zittel, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014384
- Sponsor's protocol ID
- Cereb_tDCS_in_CD
- Status last verified
- May 2026
- First submitted
- 19 May 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7778843Porcacchia 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.
PubMed 30682155Nitsche 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.
PubMed 10990547Hamada 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.
PubMed 22473780Grimm 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.
PubMed 37641392Brighina 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.
PubMed 18815775Albanese 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.
PubMed 23649720
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham-controlled Study of Cerebellar Transcranial Direct Current Stimulation (tDCS) and Its Effects on the Neurophysiological Properties of the Sensorimotor Network and Motor Symptom Severity in Patients With Isolated Cervical Dystonia (CD)
- ClinicalTrials.gov ID
- NCT07014384
- Acronym / sponsor ID
- Cereb_tDCS_in_CD
- Conditions
- Isolated Cervical Dystonia
- Keywords
- Isolated Cervical Dystonia, Transcranial direct current stimulation (tDCS), Transcranial magnetic stimulation (TMS), Sensorimotor network, Cerebellum, Non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dystonia is a movement disorder characterized by involuntary, sustained or intermittent muscle contractions, resulting in abnormal movements and postures. CD is the most common form of focal dystonia. It is characterized by abnormal postures or movements of the head. Standard treatment in patients with CD includes regular botulinum toxin injections and physical therapy, but many patients continue to experience symptoms, especially towards the end of the treatment cycle, highlighting the need for alternative treatment options.
One of the challenges in treating CD is the incomplete understanding of its underlying neurophysiological mechanisms. Recently, CD has been recognized as a network disorder, affecting the basal ganglia, the brainstem, the sensorimotor cortex and the cerebellum. So far, there is increasing evidence supporting the role of the cerebellum in the pathophysiology of dystonia, including animal models, neuroimaging and neurophysiological studies, but the exact the role in the proposed dystonia network is only incompletely understood.
TDCS is a form of non-invasive brain stimulation modulating the excitability of superficially located neurons. CtDCS is known to modulate the excitability of neurons of the cerebellar cortex, while the cerebellar nuclei and the brain stem remain unaffected. It has been shown that anodal ctDCS increases and cathodal ctDCS decreases the excitability of the cerebellum.
This randomized and sham-controlled clinical trial aims to investigate the effects of anodal and cathodal ctDCS in CD patients, focusing on both the sensorimotor network excitability and motor symptom severity. Participants will undergo three separated experimental sessions separated by one week, each with a different stimulation condition: anodal, cathodal, and sham ctDCS. Both, the study participants and the experimenter will be blinded to the order of stimulation mode.
The outcome measures will include:
- Changes in the sensorimotor network before and after ctDCS stimulation, assessed by TMS. Measurements include four main metrics to determine the neurophysiological properties of the sensorimotor network in different ways:
- Single-pulse TMS (SP-TMS) of the left primary motor cortex, used to quantify the amplitude of motor-evoked potentials (MEPs) in response to unconditioned stimuli,
- Short-interval intracortical inhibition (SICI),
- Short-latency afferent inhibition (SAI),
- Cerebellar brain inhibition (CBI).
- Clinical motor symptom severity, assessed with the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) before and after each session.
This study aims to improve the understanding of the neurophysiological mechanisms and clinical effects of ctDCS in isolated CD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal ctDCS | Active comparator | Device: Anodal and cathodal ctDCSPatients receive anodal ctDCS stimulation for 20 minutes with 2 mA |
| Cathodal ctDCS | Active comparator | Device: Anodal and cathodal ctDCSPatients receive cathodal ctDCS stimulation for 20 minutes with 2 mA |
| Sham stimulation | Sham comparator | Device: Sham stimulationPatients receive ctDCS stimulation for 20 minutes with 0 mA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of isolated cervical dystonia
- Written informed consent by the patient
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal and cathodal ctDCSCtDCS 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. | Device | Anodal ctDCS, Cathodal ctDCS |
| Sham stimulationThe tDCS procedure will be identical to the active (anodal and cathodal) stimulation condition, but stimulation will cease after 30 seconds. | Device | Sham stimulation |
Primary outcome
Changes in sensorimotor network
Time frame: Baseline (pre-intervention) and immediately after the intervention
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.
1 secondary outcome
Clinical symptom severity
Time frame: Baseline (pre-intervention) and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Results publication: PubMed 7778843Ugawa 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.
- Results publication: PubMed 30682155Porcacchia 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.
- Results publication: PubMed 10990547Nitsche 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.
- Results publication: PubMed 22473780Hamada 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.
- Results publication: PubMed 37641392Grimm 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.
- Results publication: PubMed 18815775Brighina 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.
- Results publication: PubMed 23649720Albanese 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal and cathodal ctDCS in people with Isolated Cervical Dystonia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sensorimotor network (time frame: Baseline (pre-intervention) and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07014384, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.