Electrical Neuromodulation for Focal Epilepsy

Epilepsy Clinical Trial

Official title:

Electrical Neuromodulation for Focal Epilepsy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05844696
• Other study ID #: 202207164DINA
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: May 1, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2023
• Source: National Taiwan University Hospital
• Contact: Tun JAO, M.D., Ph.D.
• Phone: +886-2-23123456
• Email: tj264[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: August 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events	Any noxious, unintended and undesired effect	3 months
Secondary	The seizure frequency per month	Seizure per month	3 months