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Machine-Learning Based EEG Biomarkers for Personalized Interventions

NCT06531317 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2024-07-31

No results posted yet for this study

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

Interventions

DEVICE

transcranial Direct Current Stimulation

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).

DIAGNOSTIC_TEST

Electroencephalography

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

Sponsors & Collaborators

  • Castellers de la Vila de Gràcia

    collaborator UNKNOWN

  • Institut Guttmann

    lead OTHER

Principal Investigators

  • Dolors Soler, PhD · Institut Guttmann

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-05
Primary Completion
2025-11-07
Completion
2025-11-07

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06531317 on ClinicalTrials.gov