Electrical Neuromodulation for Focal Epilepsy

NCT05844696 | Unknown Phase 1

• 1 other identifier: 202207164DINA
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research is to use electrical neuromodulation on patients with focal epilepsy. The main objective is to assess safety and observe potential therapeutic effects.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  Any noxious, unintended and undesired effect

  3 months

Secondary Outcomes (1)

• The seizure frequency per month

  3 months

Study Arms (3)

Sham stimulation

SHAM COMPARATOR

Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.

continuous tDCS

EXPERIMENTAL

Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.

slow-oscillatory tDCS

EXPERIMENTAL

Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.

Interventions

Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform. DEVICE

〔Part 1〕Using Soterix MXN-5 HD-tES Model 5005A. Three treatment groups: sham control, continuous tDCS, slow-oscillatory tDCS. 〔Part 2〕Using Medtronic Percept DBS platform. Single group:Neuromodulation.

Sham stimulation; continuous tDCS; slow-oscillatory tDCS

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part 1
• Age ≥ 20 years old.
• Focal epilepsy patients having received EEG and brain imaging studies and on standard medication.
• Part 2
• Age ≥ 20 years old.
• Focal epilepsy patients having received EEG and brain imaging studies and on standard medication for at least 1 year.
• Having received part I intervention.

You may not qualify if:

• Part 1
• Patients with secondary and progressive macrostructural abnormalities in the brain, such as brain tumors or infectious lesions. This does not include abnormalities directly related to epilepsy, such as mesial temporal sclerosis or focal dysplasia.
• Patients who are unable to undergo brain electrical stimulation, including those with metal in the brain or implanted stimulators/implants.
• Patients with allergies to the sponge material used for stimulation.
• Patients with wounds or infections at the site of sponge application.
• Patients with intellectual disabilities, manic episodes (with a score of greater than 12 on the Young Mania Rating Scale), major physiological illnesses (such as stroke, brain tumors, or heart attacks), or pregnant or breastfeeding women.
• Patients judged by the physician to be unsuitable for the clinical trial due to unstable vital signs or serious internal or external medical conditions.
• Part 2
• Patients with secondary and progressive macrostructural abnormalities in the brain, such as brain tumors or infectious lesions. This does not include abnormalities directly related to epilepsy, such as mesial temporal sclerosis or focal dysplasia.
• Patients who could be considered for single focus resection based on the neurologist/neurosurgeon's judgment. However, patients who clearly refuse resection surgery are not subject to this limitation.
• Patients who experience serious adverse events (SAEs) during the part 1 trial.
• Patients who are unable to undergo magnetic resonance imaging (MRI).
• Patients who are planned to receive hyperthermia therapy or transcranial magnetic stimulation.
• Patients judged by the physician to be unsuitable for the clinical trial due to unstable vital signs or serious internal or external medical conditions.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Tun JAO, M.D., Ph.D.

CONTACT

+886-2-23123456; tj264@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 6, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share