Electroencephalographic (EEG) Profils for Patients on Intravenous Ketamine.

NCT05949554 | Withdrawn

• 2 other identifiers: APHP2303522023-A00080-45
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic pain symptoms can lead to sleep and mood disorders, restrict domestic and work activities and have a significant impact on quality of life. The prevalence of chronic pain in the general population varies between 10 and 52% depending on the study, 7% of which is neuropathic pain. Anxiety-depression comorbidities are found in a large number of patients, with harmful consequences on pain since they exacerbate symptoms and their repercussions. Conversely, pain increases psychological distress. Ketamine has been used in the context of depressive episodes for its rapid action. It is also increasingly used in chronic pain due to its ability to regulate the "wind-up" effect, a phenomenon involved in the central hypersensitization that is inevitably present in neuropathic pain of prolonged duration. Several studies have found electroencephalographic (EEG) signatures associated with a good antidepressant response to Ketamine. The frequency, absolute and relative power and cordance of the EEG signal in certain frequency ranges (theta, alpha, beta and gamma) could be useful to guide and adapt therapies for depression and pain.

Conditions

Neuropathic Pain

Keywords

Pain medicine; EEG biomarkers; Refractory neuropathic pain; Ketamine

Outcome Measures

Primary Outcomes (1)

• Characterizing the EEG signature of chronic pain patients before and during intravenous Ketamine infusion

  Analysis of EEG changes by calculating absolute and relative power and cordance of the EEG signal in certain frequency ranges at different times of the infusion before and during Ketamine infusion at W1 and W3 EEG recording and its changes before and during Ketamine infusion at W1 and W3.

  Week 3

Secondary Outcomes (4)

• To establish a correlation between improvement in pain after ketamine and anxiety-depressive symptoms.

  Week 3

• To characterize the EEG signature of chronic pain patients in different subgroups as depressed and catastrophism

  Week 3

• To establish the absence of cognitive dysfunction after infusion of Ketamine.

  Week 3

• To characterize the EEG signature of chronic pain patients in different subgroups as depressed and catastrophism

  Week 3

Interventions

Ketamine infusion OTHER

Continuous measurement of burst suppression (BS) (%) and 95% spectral frequency front (SEF95) on frontal EEG Sedline® Masimo Corporation, USA). EEG recording will start 10 minutes before the beginning of infusion until the total amount of 10 milligrams of Ketamine has been infused. The duration varies depending on patient's weight. Each patient will receive a dose of 0,5 mg/kg over a period of time of 2 or 4 hours.

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

Adults aged 18 or over hospitalized for Ketamine infusion in the context of neuropathic pain in the Department of Pain Medicine at Lariboisière Hospital

You may qualify if:

• Patients \> 18 years old
• Eligible for Ketamine infusions in the context of chronic pain refractory to usual therapies
• Patient informed and having expressed his non-objection to participation in this research
• Patient who is not subject to a legal protection measure

You may not qualify if:

• Patients under 18 years of age.
• Patients with a contraindication to ketamine.
• Patient opposed to protocol participation
• Pregnant woman
• Patient under legal protection
• Patient not affiliated to a social security scheme

Sponsors & Collaborators

• M3DISIM: collaborator
• Assistance Publique - Hôpitaux de Paris: lead
• INSERM UMR-942, Paris, France: collaborator

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabrice VALLEE, MD, PhD

  Assistance Publique - Hôpitaux de Paris, Lariboisière Hospital, Department of Anesthesiology and Intensive Care

  PRINCIPAL INVESTIGATOR

• Joaquim MATEO, MD

  Assistance Publique - Hôpitaux de Paris, Lariboisière Hospital, Department of Anesthesiology and Intensive Care

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 27, 2026

Record last verified: 2026-03