NCT05361993

Efficacy of Biofeedback in the Treatment of Tic Disorder

Efficacy of Biofeedback in the Treatment of Tic Disorder：A Randomized Controlled Trial

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 8 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy of EEG biofeedback and drug therapy in the treatment of tic disorders

Detailed description

This study intends to investigate the efficacy of EEG biofeedback and drug therapy on clinical symptoms, cognitive flexibility and quality of life in chronic tic disorder and Tourette syndrome through a randomized controlled study.

Conditions

• Tic Disorders

Interventions

Type	Name	Description
DRUG	Drug Aripiprazole	Considering the patients with chronic tic disorder (chronic motor or vocal tic disorder or Tourette's disorder), aripiprazole was selected as a single drug with constant dose during the treatment. In case of extrapyramidal side effects, benhexol was given to reduce the extrapyramidal side effects, and the dosage and duration of medication were recorded
DEVICE	biofeedback	Biofeedback therapy Biofeedback therapy, three times a week, every other day interval, 30 minutes each time, each subject received 20 biofeedback training（using the Infiniti3000A biofeedback system，Thought Technology Ltd.）.Patients in the theta group decreased the theta amplitude at Cz. Patients in the theta group received positive feedback when their theta activity was below the feedback threshold.

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-05-05
• Last updated: 2025-01-20

Locations

1 site across 1 country: China