Machine-Learning Based EEG Biomarkers for Personalized Interventions

NCT06531317 | Recruiting

• 1 other identifier: 2023412
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to develop a machine learning model to predict the outcome of a transcranial direct current stimulation (tDCS) treatment in patients suffering from neuropathic pain derived from a spinal cord injury. The main question it aims to answer is:

• Can electroencephalography (EEG) and clinical assessment data predict the success of tDCS treatment in neuropathic pain patients? Participants will:
• Undergo EEG recording sessions to collect brain activity data before treatment.
• Complete clinical assessments, including medical diagnostics and questionnaires focused on factors related to neuropathic pain before and after treatment.

Conditions

Neuropathic Pain; Spinal Cord Injuries; Central Neuropathic Pain

Keywords

Neuropathic Pain; EEG; Machine Learning; Spinal Cord Injury; tDCS

Outcome Measures

Primary Outcomes (1)

• Patient Improvement as assessed by a composite score

  Composite Score Breakdown: Neuropathic Pain Symptom Inventory (NPSI) Items: * Constant pain intensity: Questions 1, 2, 3, 11, 12 (sum) * Constant pain persistence/frequency: Question 4 * Pain crisis intensity: Questions 5, 6 (sum) * Pain crisis frequency: Question 7 * Allodynia: Questions 8, 9, 10 (sum) Criteria: * Numerical NPSI items are only used where pre-treatment pain ratings are 4/10 or higher. * Responder: Any NPSI item shows a 50% or larger reduction. Brief Pain Inventory (BPI) Items: * Pain Interference: Questions 3a - 3g (average) Criteria: * Responder: 30% improvement or more. Summary: A subject is considered a responder if BOTH of these conditions are met: 1. Improvement of 50% or more in pain intensity or frequency (NPSI). 2. Improvement of 30% or more in pain interference (BPI).

  After tDCS treatment (compared to score before tDCS treatment)

Study Arms (1)

NP Subjects

Subjects suffering from NP pain after an SCI. Will receive a tDCS treatment.

Device: transcranial Direct Current Stimulation; Diagnostic Test: Electroencephalography

Interventions

transcranial Direct Current Stimulation DEVICE

The treatment follows an approved neuromodulation protocol at our center (approved on Nov. 4 2021, valid until Nov. 4 2024). tDCS will be administered with a battery-powered DC stimulator (Sooma tDCS, Helsinki, Finland), using saline-saturated circular electrodes with a diameter of 6 cm². The anode will be positioned over C3 to stimulate the primary motor cortex (M1), and the cathode over the contralateral supraorbital area (FP2). For asymmetric pain, stimulation targets the M1 contralateral to the more painful side, and for symmetric pain, the dominant hemisphere (C3) is stimulated. The maximum current is 2 mA (current density: 0.06 mA/cm²). Each session lasts 30 minutes, conducted daily for two weeks (Monday to Friday), totaling 10 sessions. All stimulation parameters adhere to general safety guidelines for transcranial electrical stimulation (Bikson et al., 2016).

Also known as: tDCS, tCS

NP Subjects

Electroencephalography DIAGNOSTIC_TEST

64-channel active-electrode EEG with impedances kept \~5KOhm

Also known as: EEG

NP Subjects

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with spinal cord injury (SCI) suffering from neuropathic pain (NP).

You may qualify if:

• Age: Over 18 years old.
• Neuropathic Pain (NP): Subacute NP at or below the lesion level for at least 1 month following spinal cord injury or disease. Persistent NP is defined as pain in an area of sensory abnormality corresponding to the spinal cord injury according to international criteria (Bryce et al. 2012). The pain should not be primarily related to spasms or any other movement.
• Pain Intensity: At least 4 out of 10 on the Numerical Rating Scale (NRS) at the time of screening (rated during the previous 24 hours).
• Pharmacological Treatment: Stable treatment including antiepileptic, antidepressant, or antispastic drugs (Gabapentin (GBP) with a minimum dose of 900 mg/day, Pregabalin (PGB) with a minimum dose of 150 mg/day, Amitriptyline with a minimum dose of 25 mg/day). No dose changes for at least 2 weeks prior to treatment and no additional antiepileptic medication. The pharmacological regimen must be maintained without changes during the 10-day stimulation period and until the electrophysiological measurement. It is recommended to keep the regimen stable until the completion of the following two evaluations (4 and 12 weeks after the end of treatment). Only paracetamol or anti-inflammatory drugs are allowed as rescue treatment.

You may not qualify if:

• Patients with severe pain (NRS \> 7) from other sources, such as musculoskeletal pain, inflammatory pain, or cancer-related pain.
• Subjects with traumatic brain injury.
• Subjects with alcohol abuse.
• Subjects with neurological diseases other than the specified spinal cord injury.
• Subjects with substance abuse.
• Subjects with any other chronic medical condition where transcranial tDCS is relatively contraindicated, such as pregnancy or epilepsy.

Sponsors & Collaborators

• Institut Guttmann: lead
• Castellers de la Vila de Gràcia: collaborator

Study Sites (1)

Institut Guttmann

Badalona, Barcelona, 08196, Spain

RECRUITING

Related Publications (6)

• Gewandter JS, McDermott MP, Evans S, Katz NP, Markman JD, Simon LS, Turk DC, Dworkin RH. Composite outcomes for pain clinical trials: considerations for design and interpretation. Pain. 2021 Jul 1;162(7):1899-1905. doi: 10.1097/j.pain.0000000000002188. No abstract available.

  PMID: 33449513 BACKGROUND

• Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.

  PMID: 27372845 BACKGROUND

• Zhdanov A, Atluri S, Wong W, Vaghei Y, Daskalakis ZJ, Blumberger DM, Frey BN, Giacobbe P, Lam RW, Milev R, Mueller DJ, Turecki G, Parikh SV, Rotzinger S, Soares CN, Brenner CA, Vila-Rodriguez F, McAndrews MP, Kleffner K, Alonso-Prieto E, Arnott SR, Foster JA, Strother SC, Uher R, Kennedy SH, Farzan F. Use of Machine Learning for Predicting Escitalopram Treatment Outcome From Electroencephalography Recordings in Adult Patients With Depression. JAMA Netw Open. 2020 Jan 3;3(1):e1918377. doi: 10.1001/jamanetworkopen.2019.18377.

  PMID: 31899530 BACKGROUND

• Vuckovic A, Gallardo VJF, Jarjees M, Fraser M, Purcell M. Prediction of central neuropathic pain in spinal cord injury based on EEG classifier. Clin Neurophysiol. 2018 Aug;129(8):1605-1617. doi: 10.1016/j.clinph.2018.04.750. Epub 2018 May 23.

  PMID: 29886266 BACKGROUND

• Mussigmann T, Bardel B, Lefaucheur JP. Resting-state electroencephalography (EEG) biomarkers of chronic neuropathic pain. A systematic review. Neuroimage. 2022 Sep;258:119351. doi: 10.1016/j.neuroimage.2022.119351. Epub 2022 Jun 2.

  PMID: 35659993 BACKGROUND

• Mari T, Henderson J, Maden M, Nevitt S, Duarte R, Fallon N. Systematic Review of the Effectiveness of Machine Learning Algorithms for Classifying Pain Intensity, Phenotype or Treatment Outcomes Using Electroencephalogram Data. J Pain. 2022 Mar;23(3):349-369. doi: 10.1016/j.jpain.2021.07.011. Epub 2021 Aug 21.

  PMID: 34425248 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries

Interventions

Transcranial Direct Current Stimulation; Electroencephalography

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Dolors Soler, PhD

  Institut Guttmann

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dolors Soler Fernandez, PhD

CONTACT

+34934977700; dsoler@guttmann.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Principal Investigator

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: July 31, 2024
• Study Start: October 5, 2023
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

ES (1)