N/A
N=3
Combined CBIT and rTMS to Improve Tourette's Syndrome
Tourette Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04795908 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Tic Severity — 59.3; 43.3; 37.67 score on a scale — p=0.1997
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Magnetic Stimulation (Device); Comprehensive behavioral intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tic Severity |
59.3; 43.3; 37.67 | 0.1997 |
| SECONDARY Modified Rush Videotape Tic Rating Scale (mRVTRS) |
16.5; 12.33; 9.5 | 0.076 |
| SECONDARY Beck Depression Inventory (BDI) |
17; 12; 11.3 | 0.6228 |
| SECONDARY Beck Anxiety Inventory (BAI) |
21.67; 17; 18 | 0.8984 |
| SECONDARY Yale-Brown Obsessive Compulsive Scale (Y-BOCS) |
17; 18.3; 20 | 0.8188 |
| SECONDARY Adult ADHD Self-Report Scale (ASRS) |
70.67; 64.33; 62 | 0.0288 sig |
| SECONDARY Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) |
87.33; 67.67; 64.67 | 0.0524 |
| SECONDARY High-Density EEG |
— | — |
Summary
The investigator will apply 16 sessions of repetitive transcranial magnetic stimulation (rTMS) over 4 consecutive days for adult patients suffering from Tourette's Syndrome. Following rTMS, patients will undergo 8 sessions of Comprehensive Behavioral Intervention for Tics (CBIT) over 10 weeks via telemedicine. Clinical improvement in tic severity will be the primary outcome measure. Secondary outcome measures including underlying physiological effects will be measured via functional magnetic resonance imaginge (fMRI), high-density electroencephalograhy (HD-EEG), and TMS.
Eligibility Criteria
Inclusion Criteria
- Any patient diagnosed with Tourette Syndrome > 18 years of age with moderate tic severity.
- Participants will be allowed to continue oral medications that they are taking for TS concurrently but will not be allowed to change their concurrent medication regimen throughout the duration of the study
Exclusion Criteria
- Presence of metallic objects or neurostimulators in the brain
- Pregnancy
- History of active seizures or epilepsy
- Contraindications to receiving fMRI, such as claustrophobia
- Inability to participate in CBIT due to other underlying cognitive or medical condition
Data sourced from ClinicalTrials.gov (NCT04795908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.