What side effects are associated with this type of intervention?

Common treatments for Tourette Syndrome that involve neuromodulation, such as repetitive transcranial magnetic stimulation (rTMS) and neurofeedback, generally have mild side effects. These can include headaches, scalp discomfort, and, in rare cases, seizures. Neurofeedback specifically may cause fatigue, headaches, or transient mood changes. While side effects specific to the supplementary motor area are not well-documented, these general side effects are relevant for treatments targeting this brain region.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Tourette Syndrome, primarily focusing on antipsychotic drugs such as haloperidol and pimozide, which help reduce tics. Additionally, alpha-2 adrenergic agonists like clonidine and guanfacine are also used. While real-time fMRI neurofeedback targeting the supplementary motor area is a novel approach currently under investigation, it has not yet received FDA approval. This method aims to modulate brain activity to manage tics, representing a potential future direction in the treatment of Tourette Syndrome.

What other types of research exist?

Promising novel alternatives for treating Tourette Syndrome in 2024 include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in various neuropsychiatric conditions, including depression and schizophrenia. 2) Transcranial Direct Current Stimulation (tDCS), which has been studied for its cognitive enhancement effects in bipolar disorder and other conditions. 3) Cranial Electrotherapy Stimulation (CES), which has shown safety and efficacy in a pilot study for bipolar II depression. These neuromodulation techniques offer non-invasive options that may benefit Tourette Syndrome patients.

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Behavioural Intervention

SMA Neurofeedback for Tourette Syndrome

N/A

Recruiting

Led By Michelle Hampson, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and one month post-nf

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive fMRI neurofeedback rather than medication, traditional side effects are minimal. However, participants may experience discomfort due to lying still in an MRI machine and potential anxiety related to claustrophobia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and one month post-nf

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and one month post-nf

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and one month post-nf for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in symptoms after the intervention compared to baseline

Secondary study objectives

Change in control over activity in the SMA target region during NF compared to baseline

Other study objectives

Changes in resting state functional connectivity to SMA in NF group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Neurofeedback from the SMAExperimental Treatment1 Intervention

Group II: Neurofeedback from control regionActive Control1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Tourette Syndrome often aim to modulate brain activity to reduce tics. Real-time fMRI neurofeedback targeting the supplementary motor area helps patients gain control over their tics by providing real-time visual feedback of their brain activity, allowing them to learn self-regulation techniques. This is similar to other neuromodulation techniques like repetitive transcranial magnetic stimulation (rTMS), which uses magnetic fields to stimulate specific brain regions, potentially reducing tic severity. These treatments are significant for Tourette Syndrome patients as they offer non-invasive options that can complement or reduce the need for medication, thereby minimizing side effects and improving quality of life.

Better than treated as usual: Transcranial magnetic stimulation augmentation in selective serotonin reuptake inhibitor-refractory obsessive-compulsive disorder, mini-review and pilot open-label trial.