Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia
NCT ID: NCT07245615
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-12-05
2026-06-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
cervical 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.
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.
No interventions assigned to this group
Interventions
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cervical 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
30 Years
ALL
Yes
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Locations
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Human Sensorimotor Control Laboratory
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Other Identifiers
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STUDY00024537
Identifier Type: -
Identifier Source: org_study_id
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