Oscillatory Acoustic-electric Stimulation in Patients With Disorders of Consciousness

Consciousness Disorder Clinical Trial

Official title:

Acoustic-electric Therapy in Patients With Disorders of Consciousness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04435301
• Other study ID #: Oscillatory stimulation
• Status: Completed
• Phase: N/A
• Start date: June 20, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: June 2020
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorder
• Consciousness Disorders
• Disease

Intervention

Device:
• DC-Stimulator, NeuroConn, Germany
Neurostimulation device

Locations

Country	Name	City	State
China	First Affiliated Hospital,Zhejiang University	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University	Maastricht University, Zhejiang Mingzhou Brain Rehabilitation Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coma Recovery Scale-Revised scores	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).	Day 1-5, Day 11-15
Primary	Neuropsychological assessment	EEG indicators could be used to assess the conscious level, including gamma oscillations and event-related potentials(P300).	Day 5 and Day 11
Primary	Glasgow Outcome Scale-Extended	A widely used index for outcomes after brain injury	1 year after stimulation