SMA Neurofeedback for Tourette Syndrome

Overseen by Michelle Hampson, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Yale University

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial involves using real-time brain scans to help adolescents with Tourette Syndrome or chronic tic disorder learn to control their brain activity. Participants see a graph of their brain activity and try to change it, which may help reduce their tics.

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 data supports the effectiveness of the treatment SMA Neurofeedback for Tourette Syndrome?

Research suggests that using neurofeedback to control activity in the supplementary motor area (SMA) can help reduce tics in people with Tourette Syndrome. Studies have shown that participants can learn to control this brain area, which may help manage symptoms by altering brain connectivity patterns associated with tics. ^{1 2 3 4 5}

Is SMA neurofeedback safe for humans?

Research on neurofeedback, including studies involving the supplementary motor area (SMA), suggests it is generally safe for humans. These studies have been conducted on both healthy individuals and those with conditions like Tourette Syndrome, with no significant safety concerns reported. ^{1 2 3 6 7}

How does the SMA neurofeedback treatment differ from other treatments for Tourette Syndrome?

SMA neurofeedback is unique because it uses real-time brain imaging to help patients learn to control activity in a specific brain area linked to tics, the supplementary motor area (SMA). This approach is different from traditional treatments, as it focuses on altering brain activity patterns rather than using medication or behavioral therapy. ^{1 2 3 4 6}

Research Team

Michelle Hampson, PhD

Principal Investigator

Yale University

Eligibility Criteria

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.

Subjects will be free of: 1) metal medical implants or braces, 2) pregnancy, 3) a body weight of less than 250 lbs., and 4) no claustrophobia

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

Trial Timeline

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

Treatment Details

Interventions

• Neurofeedback from control region (Behavioural Intervention)
• Neurofeedback from the SMA (Behavioural Intervention)

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.

Participant Groups

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+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized, Sham-Controlled Trial of Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Tics in Adolescents With Tourette Syndrome. [2021]

2. United States 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. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Protocol description for a randomized controlled trial of fMRI neurofeedback for tics in adolescents with Tourette Syndrome. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Gilles de la Tourette syndrome and voluntary movement: a functional MRI study. [2008]

5. United States pubmed.ncbi.nlm.nih.gov

Upregulation of Supplementary Motor Area Activation with fMRI Neurofeedback during Motor Imagery. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Neurofeedback and its possible relevance for the treatment of Tourette syndrome. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Enhancing Motor Network Activity Using Real-Time Functional MRI Neurofeedback of Left Premotor Cortex. [2020]