Efficacy of Biofeedback in the Treatment of Tic Disorder

NCT05361993 | Withdrawn Phase 4

• 1 other identifier: TD_BF_RCT20220318
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tic Disorders

Keywords

biofeedback; drug therapy; Clinical Efficacy; Cognitive flexibility

Outcome Measures

Primary Outcomes (8)

• 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.

  baseline assessment (T0)

• 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.

  assessment after 4 weeks of treatment (T1)

• 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.

  assessment after 8 weeks of treatment (T2)

• 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.

  3-month follow-up after completion of treatment (T3).

• 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.

  baseline assessment (T0)

• 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.

  assessment after 4 weeks of treatment (T1)

• 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.

  assessment after 8 weeks of treatment (T2)

• 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.

  3-month follow-up after completion of treatment (T3)

Secondary Outcomes (8)

• Color-word Stroop task

  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)

• The Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)

  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)

• The parent version of Swanson, Nolan, and Pelham-IV(SNAP-IV)

  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)

• Children' s Depression Inventory(CDI)

  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)

• The Screen for Child Anxiety Related Emotional Disorders(SCARED)

  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)

Study Arms (2)

Biofeedback therapy

EXPERIMENTAL

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.

Device: biofeedback

Drug therapy

ACTIVE COMPARATOR

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

Drug: Drug Aripiprazole

Interventions

Drug Aripiprazole 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

Drug therapy

biofeedback 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.

Biofeedback therapy

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Shanghai Normal University: collaborator

Study Sites (1)

Children's hospital of Fundan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Tic Disorders

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychotherapist

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: May 5, 2022
• Study Start: June 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)