SMA Neurofeedback for Tourette Syndrome

Overseen By Cheyenne Harris-Starling

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Autism, Bipolar, Psychotic, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether neurofeedback, a technique to help control brain activity, can manage symptoms of Tourette Syndrome or chronic tic disorder in children. Participants will receive real-time feedback through fMRI, a type of brain scan, targeting specific brain areas to determine if it can reduce tics. The trial seeks children aged 10-16 who have active tics but can still move their heads during treatment. Participants should live within two hours of Yale Medical Center and be able to attend regular visits. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to new treatment options.

Do I have to stop taking my current medications for the trial?

No, you don't have to stop taking your current medications. The trial requires that your medication treatment is stable and that there are no planned changes during the study.

What prior data suggests that this neurofeedback technique is safe for adolescents with Tourette Syndrome?

Research has shown that a technique called neurofeedback is being tested to help reduce tics in teenagers with Tourette Syndrome. This method uses real-time brain scans to teach children how to control their brain activity.

In earlier studies, participants tolerated this neurofeedback approach well. Any side effects, such as minor headaches or slight tiredness, were mild and temporary, similar to those from MRI procedures. No serious side effects have been reported so far.

Overall, evidence suggests that SMA neurofeedback is safe, as it provides feedback on brain activity without invasive procedures. As with any new treatment, staying informed and discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using neurofeedback from the supplementary motor area (SMA) to treat Tourette Syndrome because it offers a novel approach to managing this condition. Unlike traditional treatments like medications that often target neurotransmitters, neurofeedback involves training the brain to self-regulate its activity. This method is non-invasive and may lead to fewer side effects compared to standard drug therapies. Additionally, by providing real-time feedback and helping patients gain control over their symptoms, it has the potential to offer a more personalized and empowering treatment experience.

What evidence suggests that this trial's neurofeedback treatments could be effective for Tourette Syndrome?

This trial will compare two neurofeedback techniques for managing Tourette Syndrome. Participants will be randomly assigned to receive either Neurofeedback from the SMA or Neurofeedback from a control region. Studies have shown that neurofeedback might help reduce tics in people with Tourette Syndrome. In previous research, this method helped teenagers learn to control their brain activity, leading to fewer tics. The process uses real-time brain scans to teach users how to adjust their brain activity independently. Early results suggest that this approach could be a promising way to manage symptoms of Tourette Syndrome. ^{1 3 6 7 8}

Who Is on the Research Team?

Michelle Hampson, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 10-16 with Tourette Syndrome or chronic tic disorder, who can perform tics without moving their head. They must have a certain score on the YGTSS scale, be stable on current medications, live within 2 hours of Yale Medical Center, speak English, and not have metal implants/braces or claustrophobia.

Inclusion Criteria

Children and their parents are expected to be able to speak and understand spoken English in order to participate in a clinical assessment of TS and related psychopathology

My current medications are stable, and I don't plan to change them during the study.

I am between 10 and 16 years old.

Exclusion Criteria

My IQ is below 80.

I started psychotherapy more than 8 weeks ago or haven't started at all.

Current diagnosis of autism spectrum disorder, bipolar or psychotic disorder, or current suicidality

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neurofeedback Training

Participants undergo three fMRI neurofeedback sessions targeting either the supplementary motor area or a control region, with six NF scans per session.

3 sessions

3 visits (in-person)

Follow-up

Participants are monitored for changes in symptoms and functional connectivity to the SMA after neurofeedback training.

1 month

Multiple assessments at 4 days, 2 weeks, and 1 month post-NF

What Are the Treatments Tested in This Trial?

Interventions

• Neurofeedback from control region
• Neurofeedback from the SMA

Trial Overview Adolescents are randomly assigned to receive either real neurofeedback from the supplementary motor area (SMA) or from a control region using fMRI technology. The goal is to see if targeting the SMA helps manage symptoms of Tourette Syndrome better than the control.

How Is the Trial Designed?

Group I: Neurofeedback from the SMA Experimental Treatment 1 Intervention

Group II: Neurofeedback from control region Active Control 1 Intervention

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Functional magnetic resonance imaging (fMRI) revealed that a Tourette syndrome (TS) patient showed continuous activation of the supplementary motor area (SMA) during both usual and unusual voluntary movements, indicating its role in movement control.

The absence of tics during these voluntary tasks suggests that the patient may suppress tic activity through increased mental effort, highlighting a potential mechanism for managing tics in TS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gilles de la Tourette syndrome and voluntary movement: a functional MRI study. Fattapposta, F., Restuccia, R., Colonnese, C., et al.[2008]

A new randomized controlled trial is being set up to test a neurofeedback intervention for Tourette Syndrome and chronic tic disorder, building on promising results from a previous small study with 21 adolescents.

The intervention uses fMRI to help participants learn to control activity in the supplementary motor area of the brain, with a focus on transparency in the study design to aid future neurofeedback research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol description for a randomized controlled trial of fMRI neurofeedback for tics in adolescents with Tourette Syndrome. Awasthi, J., Harris-Starling, C., Kalvin, C., et al.[2023]

Healthy volunteers can successfully increase activity in the left premotor cortex (PMC) during a motor imagery task using fMRI neurofeedback, indicating the potential for self-regulation of brain activity.

The neurofeedback group not only enhanced PMC activity but also showed increased activation in other motor control regions, suggesting that this technique could be beneficial for rehabilitation in conditions like stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Motor Network Activity Using Real-Time Functional MRI Neurofeedback of Left Premotor Cortex. Marins, TF., Rodrigues, EC., Engel, A., et al.[2020]

In a study using fMRI neurofeedback, healthy participants were able to significantly increase activity in their supplementary motor area (SMA) during a motor imagery task, indicating that neurofeedback can help individuals self-regulate specific brain regions.

This increase in SMA activity was associated with improved behavioral performance, as participants showed shorter reaction times in a Go/No-go task, suggesting potential applications for neurofeedback in rehabilitation for motor dysfunctions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upregulation of Supplementary Motor Area Activation with fMRI Neurofeedback during Motor Imagery. Al-Wasity, S., Vogt, S., Vuckovic, A., et al.[2022]

In a study using biofeedback from real-time fMRI, healthy subjects did not initially gain control over their supplementary motor area (SMA), but they were able to exert significant control in later sessions, indicating potential for learning and adaptation.

Biofeedback led to changes in resting state functional connectivity, specifically reducing the influence of subcortical regions on the SMA, which may help in developing conscious control over this area and could be beneficial for conditions like Tourette syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback of real-time functional magnetic resonance imaging data from the supplementary motor area reduces functional connectivity to subcortical regions. Hampson, M., Scheinost, D., Qiu, M., et al.[2021]

Neurofeedback shows promise as a therapeutic option for improving executive control functions in individuals with Gilles-de-la-Tourette syndrome (GTS), particularly when ADHD symptoms are present, as these deficits may be linked to underlying brain circuit dysfunctions.

Despite the potential benefits, research on the use of neurofeedback for cognitive dysfunctions in GTS is limited, highlighting the need for further studies to explore its effectiveness and integration into treatment strategies for comorbid GTS and ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback and its possible relevance for the treatment of Tourette syndrome. Farkas, A., Bluschke, A., Roessner, V., et al.[2022]

In a study involving 21 adolescents with Tourette syndrome, real-time functional magnetic resonance imaging neurofeedback from the supplementary motor area significantly reduced tic severity, as measured by the Yale Global Tic Severity Scale, compared to a sham control.

Despite the reduction in tic symptoms, the study found no significant changes in the participants' control over the supplementary motor area, suggesting that while the neurofeedback intervention is effective for tics, the exact mechanism of action remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, Sham-Controlled Trial of Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Tics in Adolescents With Tourette Syndrome. Sukhodolsky, DG., Walsh, C., Koller, WN., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31668476/

Randomized, Sham-Controlled Trial of Real-Time ... The aim of this study was to test a novel intervention-real-time functional magnetic resonance imaging neurofeedback from the SMA-for reduction of tics in ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006322319315902

Randomized, Sham-Controlled Trial of Real-Time ... The aim of this study was to test a novel intervention—real-time functional magnetic resonance imaging neurofeedback from the SMA—for reduction ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7015800/

Randomized, sham-controlled trial of real-time fMRI ... This first randomized controlled trial of rt-fMRI neurofeedback in adolescents with TS suggests that this neurofeedback intervention may be helpful for ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05558566?tab=history&a=2

Record History | ver. 2: 2022-11-15 | NCT05558566 Other Outcome Measures. Changes in resting state functional connectivity to SMA in NF group. Functional connectivity is measured as temporal synchrony in the ...

5. withpower.com withpower.com/trial/phase-syndrome-10-2022-539a1

SMA Neurofeedback for Tourette Syndrome This trial involves using real-time brain scans to help adolescents with Tourette Syndrome or chronic tic disorder learn to control their brain activity.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10722977/

Protocol description for a randomized controlled trial of ... We present here the protocol for a new clinical trial of neurofeedback from the SMA for adolescents with TS. The study is registered on clinicaltrials.gov, but ...

7. researchgate.net researchgate.net/publication/335154025_Randomized_sham-controlled_trial_of_real-time_fMRI_neurofeedback_for_tics_in_adolescents_with_Tourette_Syndrome

(PDF) Randomized, sham-controlled trial of real-time fMRI ... Conclusions This first randomized controlled trial of rt-fMRI neurofeedback in adolescents with TS suggests that this neurofeedback intervention may be helpful ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05558566/neurofeedback-from-the-supplementary-motor-area-for-tourette-syndrome

Neurofeedback From the Supplementary Motor Area for ... This is a clinical trial where adolescents aged 10-16 years old with Tourette Syndrome (or chronic tic disorder) are randomized to receive ...