Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia ((CD-VTS))

University of Minnesota (UMN)

Status: Enrolling

Conditions: Cervical Dystonia

Treatments: Device: cervical vibrotactile stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07245615

STUDY00024537

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Cervical Dystonia Group

Experimental group

Description:

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.

Treatment:

Device: cervical vibrotactile stimulation

Healthy Controls

No Intervention group

Description:

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.