TMS in Anxiety-Parkinson's Disease

NCT06999330 | Enrolling By Invitation FDA Device

• 1 other identifier: A25-040
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinsons Disease (PD); Anxiety

Keywords

transmagnetic stimulation; functional MRI guided theta burst stimulation; intermittent theta burst stimulation

Outcome Measures

Primary Outcomes (6)

• Recruitment Rate

  Percentage of participant who enroll and consent based on those contacted. A higher percentage indicates higher feasibility.

  screening

• Participation Rate

  Percentage of participant who start treatment after enrollment. A higher percentage indicates higher feasibility.

  3 weeks

• Fidelity

  Percentage of participant who complete all treatment sessions. A higher percentage indicates higher fidelity.

  2 weeks

• Completion Rate

  Percentage of participant who complete 7 of the 9 treatment visits. A higher percentage indicates higher completion.

  2 weeks

• Adverse Events Rate - Safety

  Percentage of participant with adverse events. A lower percentage indicates a safer treatment.

  up to 12 weeks

• Adverse Events Safety

  Frequency of each adverse event. A higher frequency indicates a less safe treatment.

  up to 12 weeks

Secondary Outcomes (9)

• Average change between baseline and 1 week post-treatment TMS vs Sham - Anxiety Scale

  baseline, 1 week post-treatment

• Average change between baseline and 1 week post-treatment TMS vs Sham - Cognitive scale

  baseline, 1 week post-treatment

• Average change between baseline and 1 week post-treatment TMS vs Sham - Mood

  baseline, 1 week post-treatment

• Average change between baseline and 1 week post-treatment TMS vs Sham - Motor

  baseline, 1 week post-treatment

• Pre-post change between baseline and 1 week post-treatment within individuals in active TMS group - Anxiety Scale

  baseline, 1 week post-treatment

Other Outcomes (2)

• Explore the effect of TMS treatment on functional connectivity with Left 8 Av. - Change

  baseline, 1-week post treatment

• Explore the effect of TMS treatment on functional connectivity with Left 8 Av. - Names and number of anomalous parcellations

  baseline, 1-week post treatment

Study Arms (2)

Theta burst stimulation

EXPERIMENTAL

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.

Device: Theta burst stimulation active coil

Sham device

SHAM COMPARATOR

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.

Device: Sham coil

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.

Also known as: Transmagnetic stimulation, MagVenture

Theta burst stimulation

Sham coil DEVICE

MagVenture TMS Therapy sham coil

Sham device

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has Idiopathic PD defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor or rigidity and without any other known or suspected cause of Parkinsonism (according to MDS clinical diagnostic criteria for Parkinson's disease (42) Postuma et al, Movement Disorders 2015), confirmed by a fellowship trained movements disorder specialist.
• Subject has a diagnosis of anxiety based on PAS (Parkinson's anxiety scale) score of ≥ 14
• Subject is Hoehn \& Yahr stage less than or equal to 3
• Subject has a MOCA score ≥ 18
• Subject is ≥ 40 and ≤ 90 years of age
• Female subjects are post-menopausal or have a negative pregnancy test
• The subject must be proficient in speaking, reading and understanding English in order to comply with procedural testing
• Subject has provided informed written consent prior to participation. In the event that subject is legally unable to provide informed written consent due to deterioration in cognitive abilities, fully informed written consent must be provided by a legally authorized representative.
• Subject is on a stable dose (at least 1 month prior to baseline visit) of antiparkinsonian agents and is willing to remain on this dose for the duration of the study. If the subject is on a anti-depressant or anti-anxiety medication, a stable dose without changes for 1 month is also required.

You may not qualify if:

• 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.
• Inability to speak and read English.
• Anything else that, in the opinion of the PI/Clinician, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
• Subject has atypical Parkinson's syndrome(s) due to drugs (e.g., metoclopramide, neuroleptics), metabolic neurogenetic disorders (e.g., Wilson's Disease), encephalitis, cerebrovascular disease, or degenerative disease (e.g., Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, Lewy Body dementia)
• Other forms of advanced dementia (PDD, AD), or MOCA \<18
• Subject has history of any psychiatric illness that would pose a safety risk to the subject as determined by investigator.
• Subject is currently taking sedative medications that are clinically contraindicated as determined by investigator.
• Subject has undergone a recent change (\<1 month) in their anti-parkinsonian medication, or anti-depressant medication or anti-anxiety medication at the baseline visit.
• Safety risk to the subject as determined by investigator.
• Subject has participated in a clinical trial investigation within 3 months of this study

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Study Officials

• Bhavani Kashyap, MBBS, PhD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Allocation ratio = 2:1 active intervention to sham.

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 31, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)