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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's dementia. Anxiety in PD is common, has major effects on quality of life and contributes to increased disability. The reported prevalence of anxiety in PD ranges widely and is estimated up to 40%. Treatment with oral medications is not always effective or tolerated. TMS has been shown to be effective and safe in anxiety and general anxiety disorder (GAD), but there is only limited data available for Transcranial Magnetic Stimulation (TMS) treatment of anxiety in PD. Area 8Av is a parcellation based on Human connectome project within the left prefrontal cortex and is associated with GAD. Given the area's associations with mood disorders, its functional connectivity with large-scale brain networks involved in PD, and its anatomical accessibility by TMS, this may be an important target for anxiety in PD.

Research Team

Bhavani Kashyap, MBBS, PhD

Principal Investigator

HealthPartners Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+