NCT06531317 Machine-Learning Based EEG Biomarkers for Personalized Interventions
| NCT ID | NCT06531317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Guttmann |
| Condition | Neuropathic Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 58 participants |
| Start Date | 2023-10-05 |
| Primary Completion | 2025-11-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 58 participants in total. It began in 2023-10-05 with a primary completion date of 2025-11-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Dolors Soler, PhD
PRINCIPAL INVESTIGATOR
Institut Guttmann
Frequently Asked Questions
Who can join the NCT06531317 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Neuropathic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06531317 currently recruiting?
Yes, NCT06531317 is actively recruiting participants. Contact the research team at dsoler@guttmann.com for enrollment information.
Where is the NCT06531317 trial being conducted?
This trial is being conducted at Badalona, Spain.
Who is sponsoring the NCT06531317 clinical trial?
NCT06531317 is sponsored by Institut Guttmann. The principal investigator is Dolors Soler, PhD at Institut Guttmann. The trial plans to enroll 58 participants.