Back to resultsEfficacy of Biofeedback in the Treatment of Tic Disorder
Primary Purpose
Tic Disorders
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Drug Aripiprazole
biofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Tic Disorders focused on measuring biofeedback, drug therapy, Clinical Efficacy, Cognitive flexibility
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);
Sites / Locations
- Children's hospital of Fundan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biofeedback therapy
Drug therapy
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Yale global tic severity scale
Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening.
Yale global tic severity scale
Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening.
Yale global tic severity scale
Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening.
Yale global tic severity scale
Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening.
Wisconsin Card Sorting Test
The participants were asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changed discreetly from color to form or number of figures without the participants being informed. The participants had to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties were indicated by preservative errors; thus, higher scores on this test represent worse performance.
Wisconsin Card Sorting Test
The participants were asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changed discreetly from color to form or number of figures without the participants being informed. The participants had to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties were indicated by preservative errors; thus, higher scores on this test represent worse performance.
Wisconsin Card Sorting Test
The participants were asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changed discreetly from color to form or number of figures without the participants being informed. The participants had to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties were indicated by preservative errors; thus, higher scores on this test represent worse performance.
Wisconsin Card Sorting Test
The participants were asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changed discreetly from color to form or number of figures without the participants being informed. The participants had to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties were indicated by preservative errors; thus, higher scores on this test represent worse performance.
Secondary Outcome Measures
Color-word Stroop task
The Stroop task requires participants to name the ink color of a series of color words. In the congruent condition, the color name corresponds exactly to the color of each letter; in the incongruent condition, the printed word and the actual color of each letters are different. When subjects are required to report the ink color of the word, greater difficulty is experienced when they are in the incongruent condition. This difficulty can be measured by the increase in the amount of time required to complete the task (the Stroop interference effect). The measure of executive ability is the relative response delay in the Stroop interference condition as measured by response time (RT) in the incongruent condition minus RT in the neutral condition.
The Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
The CY-BOCS evaluates the severity of obsessions and compulsions, using ten items across five dimensions (time occupied by symptoms, interference, distress, resistance and degree of control over symptoms). The total severity score can range from 0 to 40. CY-BOCS total scores in the range of 14-24 are considered moderate, 25-30 moderate-severe and over 30 severe
The parent version of Swanson, Nolan, and Pelham-IV(SNAP-IV)
It contains 26 items and is scored on a 0-3 Likert scale. The scale consists of three subscales, which are three parts: attention deficit, hyperactivity/impulsivity, and oppositional defiance, and can be used for the assessment of ADHD symptoms in tic symptom comorbidity in this study.
Children' s Depression Inventory(CDI)
There are 27 items quantifying symptoms such as depressed mood, hedonic capacity, vegetative functions, self-evaluation, and interpersonal behaviors. Each item consists of three statements graded in order of increasing severity from 0 to 2; children and adolescents select the one that characterized their symptoms best during the past 2 weeks. The item scores are combined into a total depression score, which ranges from 0 to 54. A higher CDI score means a higher depressive state.
The Screen for Child Anxiety Related Emotional Disorders(SCARED)
The SCARED is a 41-item self-report measure designed to screen for DSM-IV anxiety disorders. The SCARED includes 5 factors: somatic/panic (13 items; e.g., "When I feel frightened, it is hard to breathe"), generalized anxiety (9 items; e.g., "I worry about other people liking me"), separation anxiety (8 items; e.g., "I get scared if I sleep away from home"), social phobia (7 items; e.g., "I don't like to be with people I don"t know well"), and school phobia (4 items; e.g., "I get headaches when I am at school"). The participants rated the items of each factor on a 3-point scale (0 = not true or hardly ever true, 1 = sometimes true, and 2 = true or often true). The SCARED total score, derived by adding the responses of the 41 items, ranges from 0 to 82.
Conners' Parent Rating Scale-Revised（CPRS-R）
It is suitable for children aged 3 - 16 years, and a total of 48 items in this scale include six factors: conduct problems, learning problems, psychosomatic problems, impulsive-hyperactivity, anxiety, and hyperactivity index, with a total of 48 items, which are scored on a 0-3 four-level scale.
The Clinical Global Impression-severity scale
The severity of illness subscale is designed to acquaint the patient's severity of symptoms with those of other people experiencing the same mental ailment. The CGI-S rates this severity of a 1-7 scale, with (1) representing normal symptoms, meaning the patient is not ill. The highest on the scale, (7), represents patients among the most severely ill. Right in the middle at (4), a patient will be defined as moderately ill.
Clinical Global Impressions-Improvement scale
The global improvement subscale allows the practitioner to create a comparative improvement based on the baseline of the first test. These changes reflect how symptoms have or have no improves due to treatment. The 7-point CGI-I scale rates improvement with a (1) representing a 'very much improved' patient and (7) representing a patient who has become 'very much worse' due to treatment. The rating (4) represents a patient displaying no change from the treatment.
Full Information
NCT ID
NCT05361993
First Posted
March 18, 2022
Last Updated
October 21, 2022
Sponsor
Children's Hospital of Fudan University
Collaborators
Shanghai Normal University
1. Study Identification
Unique Protocol Identification Number
NCT05361993
Brief Title
Efficacy of Biofeedback in the Treatment of Tic Disorder
Official Title
Efficacy of Biofeedback in the Treatment of Tic Disorder：A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University
Collaborators
Shanghai Normal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tic Disorders
Keywords
biofeedback, drug therapy, Clinical Efficacy, Cognitive flexibility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Drug therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Drug Aripiprazole
Intervention Description
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
Device
Intervention Name(s)
biofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Yale global tic severity scale
Description
Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening.
Time Frame
baseline assessment (T0)
Title
Yale global tic severity scale
Description
Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening.
Time Frame
assessment after 4 weeks of treatment (T1)
Title
Yale global tic severity scale
Description
Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening.
Time Frame
assessment after 8 weeks of treatment (T2)
Title
Yale global tic severity scale
Description
Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening.
Time Frame
3-month follow-up after completion of treatment (T3).
Title
Wisconsin Card Sorting Test
Description
The participants were asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changed discreetly from color to form or number of figures without the participants being informed. The participants had to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties were indicated by preservative errors; thus, higher scores on this test represent worse performance.
Time Frame
baseline assessment (T0)
Title
Wisconsin Card Sorting Test
Description
The participants were asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changed discreetly from color to form or number of figures without the participants being informed. The participants had to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties were indicated by preservative errors; thus, higher scores on this test represent worse performance.
Time Frame
assessment after 4 weeks of treatment (T1)
Title
Wisconsin Card Sorting Test
Description
The participants were asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changed discreetly from color to form or number of figures without the participants being informed. The participants had to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties were indicated by preservative errors; thus, higher scores on this test represent worse performance.
Time Frame
assessment after 8 weeks of treatment (T2)
Title
Wisconsin Card Sorting Test
Description
The participants were asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changed discreetly from color to form or number of figures without the participants being informed. The participants had to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties were indicated by preservative errors; thus, higher scores on this test represent worse performance.
Time Frame
3-month follow-up after completion of treatment (T3)
Secondary Outcome Measure Information:
Title
Color-word Stroop task
Description
The Stroop task requires participants to name the ink color of a series of color words. In the congruent condition, the color name corresponds exactly to the color of each letter; in the incongruent condition, the printed word and the actual color of each letters are different. When subjects are required to report the ink color of the word, greater difficulty is experienced when they are in the incongruent condition. This difficulty can be measured by the increase in the amount of time required to complete the task (the Stroop interference effect). The measure of executive ability is the relative response delay in the Stroop interference condition as measured by response time (RT) in the incongruent condition minus RT in the neutral condition.
Time Frame
It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
Title
The Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Description
The CY-BOCS evaluates the severity of obsessions and compulsions, using ten items across five dimensions (time occupied by symptoms, interference, distress, resistance and degree of control over symptoms). The total severity score can range from 0 to 40. CY-BOCS total scores in the range of 14-24 are considered moderate, 25-30 moderate-severe and over 30 severe
Time Frame
It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
Title
The parent version of Swanson, Nolan, and Pelham-IV(SNAP-IV)
Description
It contains 26 items and is scored on a 0-3 Likert scale. The scale consists of three subscales, which are three parts: attention deficit, hyperactivity/impulsivity, and oppositional defiance, and can be used for the assessment of ADHD symptoms in tic symptom comorbidity in this study.
Time Frame
It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
Title
Children' s Depression Inventory(CDI)
Description
There are 27 items quantifying symptoms such as depressed mood, hedonic capacity, vegetative functions, self-evaluation, and interpersonal behaviors. Each item consists of three statements graded in order of increasing severity from 0 to 2; children and adolescents select the one that characterized their symptoms best during the past 2 weeks. The item scores are combined into a total depression score, which ranges from 0 to 54. A higher CDI score means a higher depressive state.
Time Frame
It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
Title
The Screen for Child Anxiety Related Emotional Disorders(SCARED)
Description
The SCARED is a 41-item self-report measure designed to screen for DSM-IV anxiety disorders. The SCARED includes 5 factors: somatic/panic (13 items; e.g., "When I feel frightened, it is hard to breathe"), generalized anxiety (9 items; e.g., "I worry about other people liking me"), separation anxiety (8 items; e.g., "I get scared if I sleep away from home"), social phobia (7 items; e.g., "I don't like to be with people I don"t know well"), and school phobia (4 items; e.g., "I get headaches when I am at school"). The participants rated the items of each factor on a 3-point scale (0 = not true or hardly ever true, 1 = sometimes true, and 2 = true or often true). The SCARED total score, derived by adding the responses of the 41 items, ranges from 0 to 82.
Time Frame
It's a repeated measurement variable，aseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
Title
Conners' Parent Rating Scale-Revised（CPRS-R）
Description
It is suitable for children aged 3 - 16 years, and a total of 48 items in this scale include six factors: conduct problems, learning problems, psychosomatic problems, impulsive-hyperactivity, anxiety, and hyperactivity index, with a total of 48 items, which are scored on a 0-3 four-level scale.
Time Frame
It's a repeated measurement variable，aseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
Title
The Clinical Global Impression-severity scale
Description
The severity of illness subscale is designed to acquaint the patient's severity of symptoms with those of other people experiencing the same mental ailment. The CGI-S rates this severity of a 1-7 scale, with (1) representing normal symptoms, meaning the patient is not ill. The highest on the scale, (7), represents patients among the most severely ill. Right in the middle at (4), a patient will be defined as moderately ill.
Time Frame
It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
Title
Clinical Global Impressions-Improvement scale
Description
The global improvement subscale allows the practitioner to create a comparative improvement based on the baseline of the first test. These changes reflect how symptoms have or have no improves due to treatment. The 7-point CGI-I scale rates improvement with a (1) representing a 'very much improved' patient and (7) representing a patient who has become 'very much worse' due to treatment. The rating (4) represents a patient displaying no change from the treatment.
Time Frame
It's a repeated measurement variable，assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ding Qiang, master
Phone
18818239447
Ext
201102
Email
johndean@foxmail.com
Facility Information:
Facility Name
Children's hospital of Fundan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ding Qiang, master
Phone
18818239447
Ext
201102
Email
johndean@foxmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of Biofeedback in the Treatment of Tic Disorder
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