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RecruitingNCT07245615(CD-VTS)Updated Jun 10, 2026

Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia

An interventional study of cervical vibrotactile stimulation in Cervical Dystonia, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
30 Years and older
Sex
All
01

Study 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 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:

  1. clinical questionnaires;
  2. neck, wrist, and ankle proprioception testing,
  3. vibrotactile stimulation where they sit and relax
  4. neck proprioception testing
02

Conditions studied

  • Cervical Dystonia

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Keywords

  • vibrotactile stimulation
  • non-invasive
  • symptom control
  • proprioception
03

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Confirmed diagnosis of adult-onset, isolated idiopathic cervical dystonia.

Exclusion criteria

Exclusion Criteria:

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.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Cervical Dystonia Group

    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.

    Device: cervical vibrotactile stimulation

  • No intervention
    Healthy Controls

    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.

Interventions

  • Devicecervical vibrotactile stimulation

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: As part of the one-time visit, this part will take 90 minutes.

Secondary outcomes

  1. 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.

    Time frame: As part of the one-time visit, this part will take 60 minutes.

  2. 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.

    Time frame: As part of this one-time visit, 10 minutes.

  3. Fahn-Tolosa-Marin Clinical Rating Scale Score

    Tremor severity level will be evaluated with this numerical score.

    Time frame: As part of a one-time visit, 10 minutes.

06

Study locations

1 of 1 sites recruiting
  • Human Sensorimotor Control Laboratory
    Minneapolis, Minnesota 55455, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07245615
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Nov 24, 2025
Start date
Mar 10, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jun 10, 2026

Study contacts

Jürgen Konczak, PhD
Contact
jkonczak@umn.edu
612-624-4370
Jason Kang
Contact
kang0463@umn.edu
612-625-3313
Jürgen Konczak, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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