Skip to content

A multi-center clinical study on the effectiveness and safety of non-invasive brain-computer interface—magnetic resonance-guided multi-channel temporal interference stimulation (MRgTIS) in the treatment of refractory migraine

A multi-center clinical study on the effectiveness and safety of non-invasive brain-computer interface—magnetic resonance-guided multi-channel temporal interference stimulation (MRgTIS) in the treatment of refractory migraine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123821
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intractable migraine

Interventions

Fake stimulation group:Magnetic resonance guided multi-channel time-domain interference stimulation false stimulation
Real stimulus group:Magnetic resonance guided multi-channel time-domain interferometric stimulation

Sponsors

The First Affiliated Hospital of Bengbu Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Be clearly diagnosed as chronic migraine or episodic refractory migraine in accordance with the International Classification of Headache Disorders (ICHD-3); 2. Aged 18 to 65 years old; 3. Participate voluntarily and obtain informed consent from the subject or family members; 4. Able to understand written language and complete clinical scale scores. 5. Right-handed.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to MRI: pacemaker, deep brain stimulator, aneurysm clips, metal implants (except some titanium alloys) or any other metal foreign body unsuitable for MRI scanning; Suffering from claustrophobia. 2. Presence of contraindications to TIS, including intracranial implants (e.g., aneurysm clips, diverters, stimulators, cochlear implants, or electrodes); Any metal object in or near the head that cannot be safely removed; Use of medications that may interfere with the efficacy of TIS, such as barbiturates, benzodiazepines, and certain anticonvulsants; 3. Laboratory tests suggest impaired liver or renal function, or other important neurological or psychiatric diseases, such as severe cardiovascular and cerebrovascular diseases (such as unstable angina, recent stroke), epilepsy, brain tumors, history of major brain trauma, dementia, bipolar disorder or schizophrenia, etc. 4. Pregnant or lactating women. 5. Participated in other clinical trials within the past 3 months. 6. Recent history of drug or alcohol abuse.

Design outcomes

Primary

MeasureTime frame
Headache frequency;

Secondary

MeasureTime frame
Headache impact: using the Migraine Disability Assessment Scale (MIDAS);Pain severity rating: Visual Analogue Scale (VAS);Emotional state;

Countries

China

Contacts

Public ContactYe Ming

The First Affiliated Hospital of Bengbu Medical University

yeming0108@163.com+86 552 3086234

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026