Oscillatory Acoustic-electric Stimulation in Patients With Disorders of Consciousness

NCT04435301 — Not applicable, Completed, 73 participants, First Affiliated Hospital of Zhejiang University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Acoustic-electric Therapy in Patients With Disorders of Consciousness

Registry	NCT04435301
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	73 (Actual)
Sponsor	First Affiliated Hospital of Zhejiang University (Other); collaborators: Maastricht University, Zhejiang Mingzhou Brain Rehabilitation Hospital
Conditions	Consciousness Disorder
Interventions	DC-Stimulator, NeuroConn, Germany (Device)
Dates	start 2020-06-20, primary completion 2021-09-20, completion 2021-09-20, first posted 2020-06-17, last updated 2021-11-30
Locations	1 site in China

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Gamma modulation effect	Experimental	Device: 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.
Beta modulation effect	Experimental	Device: 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.
Sham modulation group	Sham comparator	Device: 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.

DC-Stimulator, NeuroConn, Germany (Device): Neurostimulation device

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Locations (1)

Facility	City	Country	Status
First Affiliated Hospital,Zhejiang University	Hangzhou, Zhejiang	China

+Publications

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. PMID 30448386

+Investigators

Benyan Luo, Study director, First Affiliated Hospital of Zhejiang University

My Notes

Public

To Read Reading Read