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Oscillatory Acoustic-electric Stimulation in Patients With Disorders of Consciousness

NCT ID: NCT04435301

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-20

Study Completion Date

2021-09-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Consciousness Disorder

Keywords

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disorders of consciousness electric stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Gamma modulation effect

40Hz current is applied by a battery-driven current stimulator(NeuroConn, Germany). Two pairs of electrodes are attached to the middle and lower part of the face to stimulate the maxillary nerve (V2) and the mandibular nerve (V3), respectively. 40Hz acoustic stimuli and 40Hz electric stimuli are synchronously applied for 40min/day, for a total of 5 days.

Group Type EXPERIMENTAL

DC-Stimulator, NeuroConn, Germany

Intervention Type DEVICE

Neurostimulation device

Beta modulation effect

28Hz current is applied by a battery-driven current stimulator. Two pairs of electrodes are attached to the middle and lower part of the face to stimulate the maxillary nerve (V2) and the mandibular nerve (V3). 28Hz acoustic stimuli and 28Hz electric stimuli are synchronously applied for 40min/day, for a total of 5 days.

Group Type EXPERIMENTAL

DC-Stimulator, NeuroConn, Germany

Intervention Type DEVICE

Neurostimulation device

Sham modulation group

Sham stimulation was identical to the 40Hz stimulation, except that the acoustic and electric stimulation were ramped down after 0.5 min to remain turned off for the remaining 39.5 min. Sham stimuli are applied for 40min/day, for a total of 5 days.

Group Type SHAM_COMPARATOR

DC-Stimulator, NeuroConn, Germany

Intervention Type DEVICE

Neurostimulation device

Interventions

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DC-Stimulator, NeuroConn, Germany

Neurostimulation device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University

OTHER

Sponsor Role collaborator

Zhejiang Mingzhou Brain Rehabilitation Hospital

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benyan Luo

Role: STUDY_DIRECTOR

The First Affiliated Hospital, Zhejiang University

Locations

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First Affiliated Hospital,Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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Fan S, Wu X, Xie M, Li X, Liu C, Su Y, Chen Y, Wu S, Ma C. Trigeminal nerve stimulation successfully awakened an unconscious patient. Brain Stimul. 2019 Mar-Apr;12(2):361-363. doi: 10.1016/j.brs.2018.11.001. Epub 2018 Nov 3. No abstract available.

Reference Type BACKGROUND
PMID: 30448386 (View on PubMed)

Other Identifiers

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Oscillatory stimulation

Identifier Type: -

Identifier Source: org_study_id