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Clinical study of a noninvasive deep brain stimulation TI technique in the treatment of refractory tic disorder in children

Clinical study of a noninvasive deep brain stimulation TI technique in the treatment of refractory tic disorder in children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106685
Enrollment
Unknown
Registered
2025-07-28
Start date
2025-01-08
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

refractory tic disorder

Interventions

CM-Pf TI Group:Temporal Interference (TI) deep brain stimulation on CM-Pf
GPi TI Group:Temporal Interference (TI) deep brain stimulation on GPi
rTMS Group:Repetitive transportation management system (rTMS)

Sponsors

Shenzhen Longhua Maternity and Child Healthcare Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age 6 to 18 years old (inclusive), gender is not limited; 2. Meet the diagnostic criteria for chronic tic disorder and TS in the DSM-5 diagnostic criteria for tic disorder: (1) Chronic tic disorder: one or more motor tics or vocal tics, but motor tics or vocal tics do not occur at the same time; onset before the age of 18; Since the first tic, the frequency of tics can increase or decrease, and the course of the disease is more than 1 year; Tic symptoms are not caused by certain drugs or substances or other medical events; (2) TS: There are multiple motor tics and one or more vocal tics at the same time, but motor tics and vocal tics do not necessarily occur at the same time; onset before the age of 18; After the first onset of tics, the frequency of tics can increase or decrease, and the duration of tics symptoms can exceed 1 year; Tic symptoms are not caused by certain drugs or substances or other medical events; 3. Meet the diagnostic criteria for refractory tic disorder: those who have been treated with classical anti-TD drugs, such as thiupriride, haloperidol or aripiprazole, for more than 1 year and still have no satisfactory efficacy.

Exclusion criteria

Exclusion criteria: 1.False refractory TD: such as misdiagnosis, improper drug selection, insufficient dose, intolerance due to adverse reactions, poor medication compliance, etc. 2.Seizures, movement disorders, chorea, dystonia caused by substances or drugs; 3.Genetic syndromes: such as Down syndrome, fragile X syndrome, tuberous sclerosis, neurospinocytosis, etc. 4.Infectious diseases: such as streptococcal infection, encephalitis, neurosyphilis, etc. 5.Poisoning factors: carbon monoxide, mercury, bee poisoning, etc. 6.Adverse drug reactions: such as methylphenidate, pimoline, amphetamine, cocaine, carbamazepine, phenobarbital, phenytoin sodium, lamotrigine, etc. 7.Contraindications of rTMS and TI: acute stage of cerebral hemorrhage, acute infectious diseases, intracranial hypertension, brain trauma, craniotomy, implanted pacemaker, stimulator, patients with metal foreign bodies in the brain, etc.

Design outcomes

Primary

MeasureTime frame
Yale Global Tic Severity Scale,YGTSS;

Secondary

MeasureTime frame
Attention Deficit Hyperactivity Disorder Rating Scale, Children's Self-awareness Scale, Conners Child Behavior Rating Scale, Children's Depression Scale, Children's Social Anxiety Scale, Children's Su;Functional Near-infrared Spectroscopy,fNIRS;

Countries

China

Contacts

Public ContactGuangfu Chen

Shenzhen Longhua District Maternal & Child Health Hospital

szchengf@163.com+86 13602628259

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026