Tourette's SyndromeNCT02205918
Brain-Behavior Interactions in Tic Suppression
An observational study of Tourette's Syndrome and Chronic Motor Tic Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to examine how the brain and environment interact to influence children's ability to suppress tics using a medical technology called Transcranial Magnetic Stimulation (TMS). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Tourette's Syndrome, Chronic Motor Tic Disorder, Chronic Vocal Tic Disorder
- What is being tested?
- Active TMS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Community sample
Who may be able to join
- Presence of motor and/or vocal tics for at least one year
- English fluency
Who cannot join
- Participants with medical conditions that are contraindicated for TMS (history of any known intracranial pathology, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, current pregnancy or girls of childbearing age not using effective contraception, or any other serious medical conditions
- Left-handedness
- Previous diagnosis of psychosis, autism spectrum disorder, mental retardation, or cognitive disability
- Inability to undergo MRI
- Substance abuse or dependence within the past year
- History of ≥3 sessions of Habit Reversal Therapy or other treatment primarily comprised of tic suppression strategies
- Current suicidal intent
- Current neuroleptic medications, as these medications are known to lower seizure threshold
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Integrative Examination of Neurobehavioral Mechanisms in Tic Suppression
The purpose of this study is to examine how the brain and environment interact to influence children's ability to suppress tics using a medical technology called Transcranial Magnetic Stimulation (TMS).
Read the detailed description
Objectives: This study will recruit youth with chronic tics. Chronic tics are the most common movement disorder in children. The goal of the study is to learn how the brain and environment influence children's ability to suppress tics. Specifically, we want to learn how tics are influenced by a certain part of the brain called the supplementary motor area (SMA). This part of the brain is thought to be more active in people with tics. This will be the first study to look at the relationship between SMA, tic suppression, and urges to tic.
Research Procedures: The study will take place over the course of three days within a week (about 5 hours total). The study will examine the relationship between the SMA and tic suppression using a non-invasive medical technology called Transcranial Magnetic Stimulation (TMS). Participants will have a diagnostic interview, MRI brain scan (used to find the location of the SMA), and TMS. Participants will be asked to try to suppress tics before and after TMS. The information that will be collected from participation includes information about tic symptoms, emotional and behavioral functioning, and brain activity (from MRI brain images and TMS results).
- Being tested
- Active TMS, Sham TMS
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active TMSOther
There will be one, 30-minute TMS session. Participants randomly assigned to this group will receive 1hz "active" TMS. Tics and urges will be monitored immediately before and after TMS.
Sham TMSOther
There will be one, 30-minute TMS session. Participants randomly assigned to this group will receive inactive ("sham") TMS. Tics and urges will be monitored immediately before and after TMS.
| Study group | Role | What they receive |
|---|---|---|
| Sham TMS | Participants in this group will receive one, 30 minute session of inactive ("sham") TMS. Receives: Other: Sham TMS | |
| Active TMS | Participants in this group will receive one, 30 minute session of 1hz TMS. Receives: Other: Active TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tic frequency
Tics will be observed and counted
Measured: Day 3
Secondary outcomes (1)
Urge to tic
The participant will be asked to give subjective ratings of premonitory urge intensity
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study start1 Jul 2017
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Conelea, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205918
- Sponsor's protocol ID
- PSYCH-2017-25550
- Status last verified
- Jul 2020
- First submitted
- 29 Jul 2014
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Examination of Neurobehavioral Mechanisms in Tic Suppression
- ClinicalTrials.gov ID
- NCT02205918
- Acronym / sponsor ID
- PSYCH-2017-25550
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine how the brain and environment interact to influence children's ability to suppress tics using a medical technology called Transcranial Magnetic Stimulation (TMS).
Detailed description
Objectives: This study will recruit youth with chronic tics. Chronic tics are the most common movement disorder in children. The goal of the study is to learn how the brain and environment influence children's ability to suppress tics. Specifically, we want to learn how tics are influenced by a certain part of the brain called the supplementary motor area (SMA). This part of the brain is thought to be more active in people with tics. This will be the first study to look at the relationship between SMA, tic suppression, and urges to tic.
Research Procedures: The study will take place over the course of three days within a week (about 5 hours total). The study will examine the relationship between the SMA and tic suppression using a non-invasive medical technology called Transcranial Magnetic Stimulation (TMS). Participants will have a diagnostic interview, MRI brain scan (used to find the location of the SMA), and TMS. Participants will be asked to try to suppress tics before and after TMS. The information that will be collected from participation includes information about tic symptoms, emotional and behavioral functioning, and brain activity (from MRI brain images and TMS results).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham TMS | – | Other: Sham TMSParticipants in this group will receive one, 30 minute session of inactive ("sham") TMS. |
| Active TMS | – | Other: Active TMSParticipants in this group will receive one, 30 minute session of 1hz TMS. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- Presence of motor and/or vocal tics for at least one year
- English fluency
Key exclusion criteria (8 listed)
- Participants with medical conditions that are contraindicated for TMS (history of any known intracranial pathology, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, current pregnancy or girls of childbearing age not using effective contraception, or any other serious medical conditions
- Left-handedness
- Previous diagnosis of psychosis, autism spectrum disorder, mental retardation, or cognitive disability
- Inability to undergo MRI
- Substance abuse or dependence within the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active TMSThere will be one, 30-minute TMS session. Participants randomly assigned to this group will receive 1hz "active" TMS. Tics and urges will be monitored immediately before and after TMS. | Other | Active TMS |
| Sham TMSThere will be one, 30-minute TMS session. Participants randomly assigned to this group will receive inactive ("sham") TMS. Tics and urges will be monitored immediately before and after TMS. | Other | Sham TMS |
Primary outcome
Tic frequency
Time frame: Day 3
Tics will be observed and counted
1 secondary outcome
Urge to tic
Time frame: Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Tourette's Syndrome
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
Recruiting
Exploring the Role of Neuroactive Steroids in Tourette Syndrome
Tourette Syndrome in Children
Active, not recruiting
Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
Tourette Syndrome
Recruiting
Integrating Exposure and Response Prevention and Habit Reversal Techniques to Treat a Tourettic Subtype of Obsessive-Compulsive Disorder (Tourettic OCD)
Obsessive - Compulsive Disorder, Tic Disorder, Chronic Motor or Vocal
RecruitingPhase 2
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
Neurodevelopmental Disorders, Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Conelea, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tourette's Syndrome and Chronic Motor Tic Disorder, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tic frequency (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.