Evaluation of EEG Power Spectrum in Patients With Traumatic Coma

NCT06321146 | Not Yet Recruiting DMC

• 1 other identifier: LY2024-029-B
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 5

Brief Summary

Development of objective, reliable, and convenient assessment methods of disorders of consciousness is crucial. We aim to conduct multicenter prospective observational study and non-invasively collect EEG from patients with traumatic coma to analyze the sequential characteristics of EEG power spectrum, and explore their prognostic value for consciousness recovery.

Conditions

Coma; Brain Injuries, Traumatic

Keywords

Coma; Traumatic brain injury; EEG power spectrum

Outcome Measures

Primary Outcomes (1)

• EEG power spectrum

  Sequential characteristics of spectral features for EEG in terms of frequency content (the 'ABCD' spectral categories)

  within 6 months after discharge

Secondary Outcomes (1)

• Coma Recovery Scale-Revised (CRS-R)

  within 6 months after discharge

Study Arms (5)

V-P shunt group

Comatose TBI patients who underwent V-P shunt surgery

Cranioplasty group

Comatose TBI patients who underwent cranioplasty surgery

SCS group

Comatose TBI patients who underwent spinal cord stimulation

RMNS group

Comatose TBI patients who underwent right median nerve stimulation

DAI group

Comatose TBI patients with diffuse axonal injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with traumatic coma above 18 years old

You may qualify if:

• Coma over 28 days due to closed traumatic brain injury
• Age above 18 years old
• Consented by legal representative

You may not qualify if:

• Unstable vital signs
• History of mental disorder or neurodegenerative diseases
• Uncontrolled epilepsy
• Unable to record scalp EEG
• Pregnancy

Sponsors & Collaborators

• RenJi Hospital: lead
• Beijing Tiantan Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• The General Hospital of Eastern Theater Command: collaborator
• Anhui No.2 Provincial People's Hospital: collaborator

Study Sites (5)

Anhui No.2 Provincial People's Hospital

Hefei, Anhui, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Xiangya Hospital, Central South University

Changsha, Hunan, China

Location

The General Hospital of Eastern Theater Command

Nanjing, Jiangsu, China

Location

Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 201114, China

Location

Related Publications (8)

• Edlow BL, Claassen J, Schiff ND, Greer DM. Recovery from disorders of consciousness: mechanisms, prognosis and emerging therapies. Nat Rev Neurol. 2021 Mar;17(3):135-156. doi: 10.1038/s41582-020-00428-x. Epub 2020 Dec 14.

  PMID: 33318675 BACKGROUND

• Schiff ND. Mesocircuit mechanisms in the diagnosis and treatment of disorders of consciousness. Presse Med. 2023 Jun;52(2):104161. doi: 10.1016/j.lpm.2022.104161. Epub 2022 Dec 20.

  PMID: 36563999 BACKGROUND

• Forgacs PB, Frey HP, Velazquez A, Thompson S, Brodie D, Moitra V, Rabani L, Park S, Agarwal S, Falo MC, Schiff ND, Claassen J. Dynamic regimes of neocortical activity linked to corticothalamic integrity correlate with outcomes in acute anoxic brain injury after cardiac arrest. Ann Clin Transl Neurol. 2017 Jan 6;4(2):119-129. doi: 10.1002/acn3.385. eCollection 2017 Feb.

  PMID: 28168211 BACKGROUND

• Comanducci A, Boly M, Claassen J, De Lucia M, Gibson RM, Juan E, Laureys S, Naccache L, Owen AM, Rosanova M, Rossetti AO, Schnakers C, Sitt JD, Schiff ND, Massimini M. Clinical and advanced neurophysiology in the prognostic and diagnostic evaluation of disorders of consciousness: review of an IFCN-endorsed expert group. Clin Neurophysiol. 2020 Nov;131(11):2736-2765. doi: 10.1016/j.clinph.2020.07.015. Epub 2020 Aug 14.

  PMID: 32917521 BACKGROUND

• Thibaut A, Schiff N, Giacino J, Laureys S, Gosseries O. Therapeutic interventions in patients with prolonged disorders of consciousness. Lancet Neurol. 2019 Jun;18(6):600-614. doi: 10.1016/S1474-4422(19)30031-6. Epub 2019 Apr 16.

  PMID: 31003899 BACKGROUND

• Alkhachroum A, Eliseyev A, Der-Nigoghossian CA, Rubinos C, Kromm JA, Mathews E, Bauerschmidt A, Doyle K, Velasquez A, Egbebike JA, Calderon AR, Roh DJ, Park S, Agarwal S, Connolly ES, Claassen J. EEG to detect early recovery of consciousness in amantadine-treated acute brain injury patients. J Neurol Neurosurg Psychiatry. 2020 Jun;91(6):675-676. doi: 10.1136/jnnp-2019-322645. Epub 2020 Apr 2. No abstract available.

  PMID: 32241920 BACKGROUND

• Curley WH, Bodien YG, Zhou DW, Conte MM, Foulkes AS, Giacino JT, Victor JD, Schiff ND, Edlow BL. Electrophysiological correlates of thalamocortical function in acute severe traumatic brain injury. Cortex. 2022 Jul;152:136-152. doi: 10.1016/j.cortex.2022.04.007. Epub 2022 Apr 15.

  PMID: 35569326 BACKGROUND

• Frohlich J, Crone JS, Johnson MA, Lutkenhoff ES, Spivak NM, Dell'Italia J, Hipp JF, Shrestha V, Ruiz Tejeda JE, Real C, Vespa PM, Monti MM. Neural oscillations track recovery of consciousness in acute traumatic brain injury patients. Hum Brain Mapp. 2022 Apr 15;43(6):1804-1820. doi: 10.1002/hbm.25725. Epub 2022 Jan 25.

  PMID: 35076993 BACKGROUND

MeSH Terms

Conditions

Coma; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Junfeng Feng, Dr.

  Renji Hospital, School of Medicine, Shanghai Jiaotong University

  STUDY DIRECTOR

• Guoyi Gao, Dr.

  Beijing Tiantan Hospital

  STUDY DIRECTOR

• Jinfang Liu, Dr.

  Xiangya Hospital of Central South University

  STUDY DIRECTOR

• Chiyuan Ma, Dr.

  The General Hospital of Eastern Theater Command

  STUDY DIRECTOR

• Yongming Zhang, Dr.

  Anhui No.2 Provincial People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Junfeng Feng, Dr.

CONTACT

13611860825; fengjfmail@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 20, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After Publication
• Access Criteria: Researchers who submit a methodologically sound study proposal that is approved by the management committee can have access to the study protocol, individual participant data and data dictionary.

Locations

CN (5)