Cervical Dystonia(CD-VTS)NCT07245615
Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia
A study testing cervical vibrotactile stimulation in people with Cervical Dystonia, run by University of Minnesota at 1 site in United States.
Trial summary
The primary goal of this clinical trial is to examine the effects of cervical vibrotactile stimulation intensity on abnormal head posture in people with cervical dystonia. The main question is: Does higher vibration intensity correct head posture to a greater extent than lower vibration intensity? Researchers will… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- cervical vibrotactile stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of adult-onset, isolated idiopathic cervical dystonia.
Who cannot join
- History of other neurological diseases, including Parkinson's disease, essential tremor, dementia, etc.
- History of peripheral nervous system disease that can impair proprioception. Deep brain stimulation implanted or denervation surgery. UBACC score lower than 15. Severe head tremors or facial muscle contractions. Regular intake of benzodiazepines or antidepressant medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Human Sensorimotor Control Laboratory
Minneapolis, Minnesota, 55455
About this study
Official title: The Effects of Different Vibro-tactile Stimulation Intensities on Head Posture in Cervical Dystonia
The primary goal of this clinical trial is to examine the effects of cervical vibrotactile stimulation intensity on abnormal head posture in people with cervical dystonia. The main question is: Does higher vibration intensity correct head posture to a greater extent than lower vibration intensity? Researchers will compare the head posture of participants with cervical dystonia who receive different intensities of vibration to cervical muscles.
The secondary goal of this clinical trial is to examine the degree of proprioceptive impairment in cervical dystonia. Specifically, the study will assess proprioceptive impairment at the neck, wrist, and ankle joints, and seeks to determine whether the impairment improves with cervical vibrotactile stimulation.
Read more
Researchers will compare the proprioception testing results of these joints between cervical dystonia patients and age- and sex- matched healthy controls. Researchers will also compare the neck proprioception testing results of cervical dystonia patients before and after stimulation.
Participants will visit the lab once for three hours, where they will go through:
- clinical questionnaires;
- neck, wrist, and ankle proprioception testing,
- vibrotactile stimulation where they sit and relax
- neck proprioception testing
- Conditions
- Cervical Dystonia
- Being tested
- cervical vibrotactile stimulation
- Keywords
- vibrotactile stimulation, non-invasive, symptom control, proprioception
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical vibrotactile stimulationDevice
The intervention in this study is vibrotactile stimulation with 3 different intensities on 4 combinations of cervical muscles. The three intensity levels are 0.25mm, 0.64mm, and 1.48mm of movement range of the vibrator, when attached to the cervical area. The four muscle combinations (left and right SCM, left and right TRP, left SCM and TRP, right SCM and TRP) are selected as they were shown to be more effective than other combinations in a previous studies. The total number of bouts of stimulation is 12 (3 intensities * 4 muscle combinations). Each VTS application is 2 minutes long, resulting in total stimulation time of 24 minutes. There will be a 5-minute break of no-vibration between each application of vibration.
During the intervention, the participant will remain seated and asked to not interfere voluntarily with dystonic muscle spasms. During breaks, they can adjust their head posture for their comfort. Extra breaks will be given if needed.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Dystonia Group | Experimental | All participants with cervical dystonia will be in this group to receive the intervention. After answer three questionnaires (The Mini Mental State Examination, the Revised Toronto Western Spasmodic Torticollis Rating Scale and Psychiatric Screening Tool, Fahn, Tolosa, Marin Tremor Rating Scale), their neck, wrist, and ankle proprioception will be tested respectively. They they will go through the intervention of cervical vibrotactile stimulation. Lastly, their neck proprioception will be tested again. Receives: Device: cervical vibrotactile stimulation |
| Healthy Controls | No intervention | Healthy people age- and sex- matched with participants with cervical dystonia will be in this group. This group will only be tested on their neck, wrist, and ankle proprioception, to compare with the cervical dystonia group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head Angle Index
The primary outcome measure is the head angle index, which quantifies how much a participant's head posture deviates from a neutral upright position. There are three degrees of freedom for the neck joint (axial rotation, lateral bending, and flexion/extension). For each participant, the degree(s) of freedom with abnormality will be identified at baseline. For any time period during the experiment, the mean absolute neck angle in each abnormal degree of freedom will be calculated and normalized by the typical maximal range of motion in healthy individuals. These normalized values will be averaged to yield the Head Angle Index.
Measured: As part of the one-time visit, this part will take 90 minutes.
Secondary outcomes (3)
Position Matching Error
The secondary outcome measure is absolute position matching error, which quantifies the position sense acuity of the participants in each joint. For each tested joint, they will be given a set of target position. The joint will be passively rotated to the target position, and back to the starting position. The participant will then try to reproduce the target position, based on their memory of the position. After repeating for 9 times, the absolute value of the differences between the matched position and the target position will be averaged to get the absolute position matching error.
Measured: As part of the one-time visit, this part will take 60 minutes.
the Toronto Western Spasmodic Torticollis Rating Scale Score
This three-part rating scale will evaluate the severity, disability and pain level of each CD participant. Each part results in a numerical score.
Measured: As part of this one-time visit, 10 minutes.
Fahn-Tolosa-Marin Clinical Rating Scale Score
Tremor severity level will be evaluated with this numerical score.
Measured: As part of a one-time visit, 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start10 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jürgen Konczak, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245615
- Sponsor's protocol ID
- STUDY00024537
- Acronym
- (CD-VTS)
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Vibro-tactile Stimulation Intensities on Head Posture in Cervical Dystonia
- ClinicalTrials.gov ID
- NCT07245615
- Acronym / sponsor ID
- (CD-VTS) / STUDY00024537
- Conditions
- Cervical Dystonia
- Keywords
- vibrotactile stimulation, non-invasive, symptom control, proprioception
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Nov 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.
The primary goal of this clinical trial is to examine the effects of cervical vibrotactile stimulation intensity on abnormal head posture in people with cervical dystonia. The main question is: Does higher vibration intensity correct head posture to a greater extent than lower vibration intensity? Researchers will compare the head posture of participants with cervical dystonia who receive different intensities of vibration to cervical muscles.
The secondary goal of this clinical trial is to examine the degree of proprioceptive impairment in cervical dystonia. Specifically, the study will assess proprioceptive impairment at the neck, wrist, and ankle joints, and seeks to determine whether the impairment improves with cervical vibrotactile stimulation.
Researchers will compare the proprioception testing results of these joints between cervical dystonia patients and age- and sex- matched healthy controls. Researchers will also compare the neck proprioception testing results of cervical dystonia patients before and after stimulation.
Participants will visit the lab once for three hours, where they will go through:
- clinical questionnaires;
- neck, wrist, and ankle proprioception testing,
- vibrotactile stimulation where they sit and relax
- neck proprioception testing
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Dystonia Group | Experimental | Device: cervical vibrotactile stimulationAll participants with cervical dystonia will be in this group to receive the intervention. After answer three questionnaires (The Mini Mental State Examination, the Revised Toronto Western Spasmodic Torticollis Rating Scale and Psychiatric Screening Tool, Fahn, Tolosa, Marin Tremor Rating Scale), their neck, wrist, and ankle proprioception will be tested respectively. They they will go through the intervention of cervical vibrotactile stimulation. Lastly, their neck proprioception will be tested again. |
| Healthy Controls | No intervention | –Healthy people age- and sex- matched with participants with cervical dystonia will be in this group. This group will only be tested on their neck, wrist, and ankle proprioception, to compare with the cervical dystonia group. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed diagnosis of adult-onset, isolated idiopathic cervical dystonia.
Key exclusion criteria (2 listed)
- History of other neurological diseases, including Parkinson's disease, essential tremor, dementia, etc.
- History of peripheral nervous system disease that can impair proprioception. Deep brain stimulation implanted or denervation surgery. UBACC score lower than 15. Severe head tremors or facial muscle contractions. Regular intake of benzodiazepines or antidepressant medication.
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 |
|---|---|---|
| cervical vibrotactile stimulationThe intervention in this study is vibrotactile stimulation with 3 different intensities on 4 combinations of cervical muscles. The three intensity levels are 0.25mm, 0.64mm, and 1.48mm of movement range of the vibrator, when attached to the cervical area. The four muscle combinations (left and right SCM, left and right TRP, left SCM and TRP, right SCM and TRP) are selected as they were shown to be more effective than other combinations in a previous studies. The total number of bouts of stimulation is 12 (3 intensities * 4 muscle combinations). Each VTS application is 2 minutes long, resulting in total stimulation time of 24 minutes. There will be a 5-minute break of no-vibration between each application of vibration. During the intervention, the participant will remain seated and asked to not interfere voluntarily with dystonic muscle spasms. During breaks, they can adjust their head posture for their comfort. Extra breaks will be given if needed. | Device | Cervical Dystonia Group |
Primary outcome
Head Angle Index
Time frame: As part of the one-time visit, this part will take 90 minutes.
The primary outcome measure is the head angle index, which quantifies how much a participant's head posture deviates from a neutral upright position. There are three degrees of freedom for the neck joint (axial rotation, lateral bending, and flexion/extension). For each participant, the degree(s) of freedom with abnormality will be identified at baseline. For any time period during the experiment, the mean absolute neck angle in each abnormal degree of freedom will be calculated and normalized by the typical maximal range of motion in healthy individuals. These normalized values will be averaged to yield the Head Angle Index.
3 secondary outcomes
Position Matching Error
Time frame: As part of the one-time visit, this part will take 60 minutes.
the Toronto Western Spasmodic Torticollis Rating Scale Score
Time frame: As part of this one-time visit, 10 minutes.
Fahn-Tolosa-Marin Clinical Rating Scale Score
Time frame: As part of a one-time visit, 10 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- 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.
Jürgen Konczak, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical vibrotactile stimulation in people with Cervical Dystonia, run by University of Minnesota at 1 site in United States.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 Oct 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 United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jürgen Konczak, PhD (612-624-4370, jkonczak@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Head Angle Index (time frame: As part of the one-time visit, this part will take 90 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.