Transcranial Magnetic Stimulation for Anxiety in Parkinson's Disease

Overseen By Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Must be taking: Antiparkinsonian agents

Must not be taking: Sedatives

Disqualifiers: Seizure disorder, Alcohol use, others

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

Compensation: Varies

Number of Visits: 28

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with Parkinson's disease who also experience anxiety. It examines a treatment called Transcranial Magnetic Stimulation (TMS), which uses magnets to target brain areas linked to anxiety. The trial includes real TMS treatment, specifically using a method called Theta Burst Stimulation, and a placebo version to compare effects. People with Parkinson's and anxiety, who have maintained the same medication dose for at least a month, might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

You will need to be on a stable dose of your current Parkinson's, anti-depressant, or anti-anxiety medications for at least one month before starting the trial and remain on that dose during the study. If you are taking sedative medications that are not allowed, you may need to stop them as determined by the investigator.

What prior data suggests that Transcranial Magnetic Stimulation is safe for treating anxiety in Parkinson's Disease?

Research has shown that Transcranial Magnetic Stimulation (TMS) is generally safe and well-tolerated for treating anxiety and conditions like general anxiety disorder. Specifically, a type of TMS called theta burst stimulation has produced positive results without major safety concerns.

For instance, studies with Parkinson's disease patients have used intermittent theta burst stimulation to improve overall function and quality of life. Although data on anxiety in Parkinson's patients is limited, existing studies suggest that theta burst stimulation typically does not cause serious side effects.

In summary, theta burst stimulation has been researched for other conditions and is considered safe, with no major side effects reported. This makes it a promising option for treating anxiety in Parkinson's disease, though more specific research is still needed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) for anxiety in Parkinson's disease is unique because it uses a non-invasive method called theta burst stimulation (iTBS) to target specific brain regions. Unlike traditional medications for anxiety, which often involve systemic drug therapy, TMS directly stimulates the brain with magnetic fields, potentially leading to fewer side effects. Researchers are excited because this method could offer rapid relief from anxiety symptoms without the need for medication, which is particularly beneficial for patients who might experience side effects or interactions with their Parkinson’s medication. Additionally, TMS sessions are relatively quick, making it a convenient option for patients.

What evidence suggests that Transcranial Magnetic Stimulation might be an effective treatment for anxiety in Parkinson's disease?

Research has shown that Transcranial Magnetic Stimulation (TMS) can be a safe and effective treatment for anxiety disorders, such as general anxiety disorder (GAD). In people with Parkinson's disease, TMS has helped with thinking and movement problems. This trial will provide participants with either intermittent theta burst stimulation (iTBS) or a sham treatment. iTBS, a specific type of TMS, has improved movement and behavior issues. Although limited data exists on using iTBS for anxiety in Parkinson's patients, its success in treating other anxiety conditions suggests potential benefits. This treatment targets a brain area related to mood disorders, which could help manage anxiety symptoms in people with Parkinson's. ^{1 6 7 8 9}

Who Is on the Research Team?

Bhavani Kashyap, MBBS, PhD

Principal Investigator

HealthPartners Institute

Are You a Good Fit for This Trial?

This trial is for Parkinson's disease patients who also suffer from anxiety. Participants should have a diagnosis of both conditions and be seeking alternative treatments beyond oral medications, which may not have been effective or tolerable for them.

Inclusion Criteria

My mental function score is 18 or higher.

The subject must be proficient in speaking, reading and understanding English in order to comply with procedural testing

My anxiety level is high based on the Parkinson's anxiety scale.

Exclusion Criteria

Inability to speak and read English

Inability to tolerate imaging; contraindication of imaging due to implants or metal. This includes an implanted deep brain stimulation device

Seizure disorder, active alcohol or substance use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive intermittent theta burst stimulation (iTBS) or sham treatment over a 3-week period, with 27 sessions in total

3 weeks

27 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of anxiety, mood, and motor symptoms

1 week

1 visit (in-person)

Long-term follow-up

Participants are monitored for adverse events and overall safety up to 12 weeks post-treatment

8-12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham Coil
• Theta Burst Stimulation

Trial Overview The study is testing Theta burst stimulation (TBS) using an active coil versus a sham (placebo) coil to see if TBS can reduce anxiety in Parkinson's patients. The target area for the treatment is within the left prefrontal cortex, known as Area 8Av.

How Is the Trial Designed?

Group I: Theta burst stimulation Experimental Treatment 1 Intervention

Subjects will receive treatment with intermittent theta burst stimulation (iTBS) with the active coil. There will be a total of 27 sessions over a 3-week period with 3 sessions per day. All subjects will receive iTBS to the left 8Av region. Total participation will be 8-12 weeks.

Group II: Sham device Placebo Group 1 Intervention

Subjects will receive treatment with sham coil. There will be a total of 27 treatments over a 3-week period. Coil will be placed over the same region as the experimental group. Total participation will be 8-12 weeks.

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10252812/

Intermittent Theta Burst Stimulation Improves Motor and ... Intermittent theta burst stimulation improves motor and behavioral dysfunction through modulation of NMDA receptor subunit composition in experimental model of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1353802025006388

Effect of periodical continuous theta burst stimulation in ... This study explores the efficacy of periodic cTBS in PD, demonstrating sustained motor symptom improvement over one year.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06999330

NCT06999330 | TMS in Anxiety-Parkinson's Disease TMS has been shown to be effective and safe in anxiety and general anxiety disorder ... Subjects will receive treatment with intermittent theta burst stimulation ...

4. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1354864/full

Effect of different modalities of transcranial magnetic ... TMS has some long-term sustained effects on improving cognitive function in Parkinson's patients. HF-rTMS is more effective in improving cognitive function in ...

5. cdnsciencepub.com cdnsciencepub.com/doi/full/10.1503/jpn.210134

Clinical effects of continuous theta burst stimulation for ... The purpose of this study was to compare the clinical effects and α oscillations induced by cTBS versus 1 Hz rTMS as predictors of response, and to assess the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10952126

Accelerated Theta Burst Stimulation (aTBS) In addition to the data for aTBS in MDD, aTBS trials have also been run in individuals with schizophrenia (n=3)(12,47,48), OCD (n=3)(17,49,50), Parkinson's ...

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07425-7

Intermittent theta-burst stimulation combined with physical ... The aim of this study is to demonstrate that iTBS can promote overall function and quality of life in Parkinson's disease patients using physiotherapy.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006322325013563

Efficacy and Safety of Accelerated Intermittent Theta-burst ... Several systematic reviews have supported TMS as a potentially effective treatment option for adolescents with MDD, suggesting that high- ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06919822

SCAN Electrical Stimulation for Parkinson's Disease This is a prospective, open-label, single-center clinical trial investigating the efficacy and safety of personalized electrical stimulation ...