NCT04435301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

June 20, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

November 30, 2021

Status Verified

June 1, 2020

Enrollment Period

1.3 years

First QC Date

June 11, 2020

Last Update Submit

November 18, 2021

Conditions

Consciousness Disorder

Keywords

disorders of consciousnesselectric stimulation

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Glasgow Outcome Scale-Extended

    A widely used index for outcomes after brain injury

    1 year after stimulation

Study Arms (3)

Gamma modulation effect

EXPERIMENTAL

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.

Device: DC-Stimulator, NeuroConn, Germany

Beta modulation effect

EXPERIMENTAL

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.

Device: DC-Stimulator, NeuroConn, Germany

Sham modulation group

SHAM COMPARATOR

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.

Device: DC-Stimulator, NeuroConn, Germany

Interventions

DC-Stimulator, NeuroConn, GermanyDEVICE

Neurostimulation device

Beta modulation effectGamma modulation effectSham modulation group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not medically stable
  • Any contraindication to electric stimulation
  • Hearing impairment before brain injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital,Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related 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. No abstract available.

    PMID: 30448386BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Benyan Luo

    The First Affiliated Hospital, Zhejiang University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 17, 2020

Study Start

June 20, 2020

Primary Completion

September 20, 2021

Study Completion

September 20, 2021

Last Updated

November 30, 2021

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)