Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cervical vibrotactile stimulation.
- Who it may be relevant to
- Registry conditions: Cervical Dystonia. Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effects of Different Vibro-tactile Stimulation Intensities on Head Posture in Cervical Dystonia
Overview
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
Interventions
- Device 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 stimulat
Primary outcome measures
- Head Angle Index [Time frame: As part of the one-time visit, this part will take 90 minutes.]
Secondary outcome measures (3)
- 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.]
Eligibility criteria
Inclusion criteria
Confirmed diagnosis of adult-onset, isolated idiopathic cervical dystonia.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Human Sensorimotor Control Laboratory — Minneapolis
Identifiers
NCT: NCT07245615 · STUDY00024537