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

NCT07245615 | Recruiting DMC

• 1 other identifier: STUDY00024537
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Cervical Dystonia

Keywords

vibrotactile stimulation; non-invasive; symptom control; proprioception

Outcome Measures

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.

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

Secondary Outcomes (3)

• Position Matching Error

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

• the Toronto Western Spasmodic Torticollis Rating Scale Score

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

• Fahn-Tolosa-Marin Clinical Rating Scale Score

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

Study Arms (2)

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.

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.

Interventions

cervical vibrotactile stimulation DEVICE

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.

Cervical Dystonia Group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Human Sensorimotor Control Laboratory

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jürgen Konczak, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jürgen Konczak, PhD

CONTACT

612-624-4370; jkonczak@umn.edu

Jason Kang

CONTACT

612-625-3313; kang0463@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 5, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)