TMS in Anxiety-Parkinson's Disease

Part of paid clinical trials in Saint Paul, Minnesota.

Sponsor
HealthPartners Institute
Study ID
NCT06999330
Status
Enrolling By Invitation

Conditions

  • Anxiety
  • Parkinsons Disease (PD)

Eligibility Criteria

Sex
ALL
Age
40 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Theta burst stimulation active coil — DEVICE
    MagVenture TMS Therapy active coil with theta burst stimulation. Resting motor threshold: 90%; Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz; Session length: 10 min; Time between sessions: 50 minutes.
  • Sham coil — DEVICE
    MagVenture TMS Therapy sham coil

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2027
Completion
Mar 30, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Theta burst stimulation
    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.
  • Sham Comparator: Sham device
    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.

Primary Outcome Measure

Recruitment Rate [ Time Frame: screening ]

Locations (1)

FacilityCityStateZIPSite coordinators
HealthPartners Neuroscience CenterSaint PaulMinnesota55130-

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