Oscillatory Acoustic-electric Stimulation in Patients With Disorders of Consciousness

Zhejiang University

Status: Completed

Conditions: Consciousness Disorder

Treatments: Device: DC-Stimulator, NeuroConn, Germany

Study type: Interventional

Funder types: Other

Identifiers

NCT04435301

Oscillatory stimulation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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73 participants in 3 patient groups

Gamma modulation effect

Experimental group

Description:

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.

Treatment:

Device: DC-Stimulator, NeuroConn, Germany

Beta modulation effect

Experimental group

Description:

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.

Treatment:

Device: DC-Stimulator, NeuroConn, Germany

Sham modulation group

Sham Comparator group

Description:

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.

Treatment:

Device: DC-Stimulator, NeuroConn, Germany