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Completed

NCT Number: NCT04435301

Oscillatory Acoustic-electric Stimulation in Patients With Disorders of Consciousness

Altered gamma activity has been observed in several neurological and psychiatric disorders, including a reduction in gamma synchronization in patients with disorders of consciousness. Modulation of gamma oscillations with rhythmic stimulation has been used as a possible therapeutic tool. Hence, we try to use acoustic and electric stimulation at gamma frequency to restore brain oscillation and thereby to improve conscious awareness in patients with disorders of consciousness.

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Key information

Conditions

Consciousness Disorder Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital,Zhejiang University

Hangzhou, Zhejiang, 310003, China

About this study

We propose a matched-pair parallel study in patients with disorders of consciousness to investigate whether combined acoustic and trigeminal nerve stimulation can modulate brain oscillations, as measured by electroencephalography (EEG), and whether the brain activity changes are coupled with improvements in consciousness.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of disorders of consciousness based on CRS-R
  • Time post-injury ranging from one to twelve months
  • No history of acquired brain injury or psychiatric or neurological diseases

Exclusion criteria

  • Not medically stable
  • Any contraindication to electric stimulation
  • Hearing impairment before brain injury

Treatment and study plan

DC-Stimulator, NeuroConn, Germany

Device

Neurostimulation device

Primary outcomes

  1. Coma Recovery Scale-Revised scores

    Time frame: Day 1-5, Day 11-15

    Coma Recovery Scale-Revised(CRS-R) scores are the gold standard for consciousness. CRS-R consists of 23 items, grouped into 6 sub-scales: auditory, visual, motor, oromotor, communication and arousal. The lowest score on each sub-scale represents reflexive activity; the highest represents behaviors mediated by cognitive input. The total score ranges between 0 (worst) and 23 (best).

  2. Neuropsychological assessment

    Time frame: Day 5 and Day 11

    EEG indicators could be used to assess the conscious level, including gamma oscillations and event-related potentials(P300).

  3. Glasgow Outcome Scale-Extended

    Time frame: 1 year after stimulation

    A widely used index for outcomes after brain injury

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Collaborators

  • Maastricht University
  • Zhejiang Mingzhou Brain Rehabilitation Hospital

Registry information

Official study title

Acoustic-electric Therapy in Patients With Disorders of Consciousness

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 17, 2020
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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