Efficacy of Biofeedback in the Treatment of Tic Disorder

NCT ID: NCT05361993

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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 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.

Group Type: EXPERIMENTAL

biofeedback

Intervention Type: DEVICE

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.

Drug therapy

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

Group Type: ACTIVE_COMPARATOR

Drug Aripiprazole

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Meet the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders(Fifth Edition,DSM-5) for chronic tic disorder or Tourette syndrome（TS）;
• Ethnic group is Han nationality;
• Aged 8 ~ 16 years old;
• otal IQ of Wechsler Intelligence Scale for Children ≥ 80 points for subjects;
• Symptom severity score in Yale Global Severity Scale (YGTSS), TS patients > 13, CTD > 9;
• Did not receive any drug (including traditional Chinese medicine) treatment 4 weeks before enrollment;
• Obtain written informed consent from children and guardians

Exclusion Criteria

• Epilepsy, cardiovascular disease
• Patients with schizophrenia, mental retardation, autism spectrum disorder, bipolar disorder and major depression who meet the DSM-5 diagnostic criteria;
• Receiving systematic traditional Chinese medicine treatment one month before enrollment or currently;
• Receiving systematic psychotherapy one month before enrollment or currently;
• Receive systematic physical therapy one month before enrollment or currently
• Those who cannot follow the doctor's advice or refuse to cooperate;
• Those with obvious abnormal laboratory test results (AST or ALT ≥ 2 times of the upper limit of normal value; bun ≥ 1.5 times of the upper limit of normal value; Cr ≥ 1.2 times of the upper limit of normal value);
• Prolongation of QTc interval (QTc ≥ 450 ms in men or ≥ 470 MS in women);

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Normal University

UNKNOWN

Sponsor Role: collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Ding Qiang

Clinical Psychotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's hospital of Fundan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

TD_BF_RCT20220318

Identifier Type: -

Identifier Source: org_study_id