Oscillatory Acoustic-electric Stimulation in Patients With Disorders of Consciousness

Not Applicable

Completed

• Conditions: Consciousness Disorder
• Interventions: Device: DC-Stimulator, NeuroConn, Germany

• Registration Number: NCT04435301
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-17
• Study Start: 2020-06-20
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gamma modulation effect	DC-Stimulator, NeuroConn, Germany	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.
Sham modulation group	DC-Stimulator, NeuroConn, Germany	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.
Beta modulation effect	DC-Stimulator, NeuroConn, Germany	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.

Primary Outcome Measures

Name	Time	Method
Coma Recovery Scale-Revised scores	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).
Neuropsychological assessment	Day 5 and Day 11	EEG indicators could be used to assess the conscious level, including gamma oscillations and event-related potentials(P300).
Glasgow Outcome Scale-Extended	1 year after stimulation	A widely used index for outcomes after brain injury

Trial Locations

Locations (1)

First Affiliated Hospital,Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China