Skip to content

Efficacy and safety of transcranial direct current stimulation for focal dystonia: a randomized double-blind controlled study

Efficacy and safety of transcranial direct current stimulation for focal dystonia: a randomized double-blind controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070920
Enrollment
Unknown
Registered
2023-04-26
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Focal dystonia

Interventions

tDCS group: The anodal stimulation target is the right cerebellar lobe VIII, and the cathode is placed on the ipsilateral buccal muscle. The stimulation intensity is 2mA, and the duration of single s
tDCS sham stimulation group: The anodal stimulation target is the right cerebellar lobe VIII, and the cathode is placed on the ipsilateral buccal muscle. The current is stopped after 10-second stimu
cTBS group: The right SMA stimulation target is imported into neuronavigation system.TMS with a figure-of-eight coil is tangential to the subject's scalp, and pulses are delivered at 80% of RMT. The
cTBS sham stimulation group: The right SMA stimulation target is imported into neuronavigation system.TMS with a figure-of-eight coil is perpendicular to the subject's scalp, and then no current is g

Sponsors

The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) A diagnosis of BSP or CD or blepharospasm-oromandibular dystonia established according to the published criteria; (2) JRS severity score of = 3 or TWSTRS severity score of = 15; (3) With poor effects of medications treatment, and with contraindications of botulinum toxin ( BoNT) treatment or serious complications such as ptosis and exposure keratitis after BoNT injection, or with rejection of BoNT injection; (4) With short remission duration less than 2 months of BoNT treatment during the 6-month observation period; (5) With primary resistance to BoNT (patients with less than 25% improvement after two or three consecutive injections of increasing doses of BoNT) or secondary resistance to BoNT after repeated injections (patients with at least 50% improvement after at least two treatment cycles, but subsequent improvement of less than 25% of baseline in two or more subsequent treatment cycles); (6) After the last BoNT treatment for at least 3 months or medications treatment at least 1 month; (7) Written informed consent was obtained from all participants.

Exclusion criteria

Exclusion criteria: (1) Any contraindications to cerebral magnetic resonance imaging (MRI) examination; (2) With acute intracranial diseases (e.g. stroke, intracranial infection, etc.); (3) With hyperalgesia, injury or inflammation of the area of stimulation; (4) A history of mental illness, depression, anxiety, dementia, epilepsy, Tourette's syndrome, Parkinson's disease or Parkinson's syndrome, or serious systemic diseases that significantly shorten life expectancy; (5) T2-weighted MRI images with abnormal white matter signal of grade 2 or above; (6) A history of participation in other clinical trials in the past 3 months.

Design outcomes

Primary

MeasureTime frame
The improvement rate of clinical symptom severity scores;

Secondary

MeasureTime frame
Effective rate;The improvement rate of clinical symptom of BSP, JRS, BSS, TWSTRS scores, and CDQ-24 scores;PEGR scores;

Countries

China

Contacts

Public ContactLiu Gang

The First Affiliated Hospital of Sun Yat-sen University

liug26@mail.sysu.edu.cn+86 18664678483

Outcome results

None listed

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