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

Официальное название

The Effects of Different Vibro-tactile Stimulation Intensities on Head Posture in Cervical Dystonia

Обзор

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

Вмешательства

• Устройство 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

Первичные конечные точки

• Head Angle Index [Срок оценки: As part of the one-time visit, this part will take 90 minutes.]

Вторичные конечные точки (3)

• Position Matching Error [Срок оценки: As part of the one-time visit, this part will take 60 minutes.]
• the Toronto Western Spasmodic Torticollis Rating Scale Score [Срок оценки: As part of this one-time visit, 10 minutes.]
• Fahn-Tolosa-Marin Clinical Rating Scale Score [Срок оценки: As part of a one-time visit, 10 minutes.]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Human Sensorimotor Control Laboratory — Minneapolis

Идентификаторы

NCT: NCT07245615 · STUDY00024537

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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