Parkinson DiseaseNCT07701785
Superior Parietal iTBS for PD-MCI
A study testing Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL) in people with Parkinson Disease and Mild Cognitive Impairment, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The goal of this study is to determine the whether a short-term, high-dose form of non-invasive brain stimulation (intermittent theta burst stimulation; iTBS) is a promising and safe treatment for mild cognitive impairment in Parkinson's disease (PD-MCI). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson Disease, Mild Cognitive Impairment
- What is being tested?
- Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-85 years of age
- Diagnosis of Parkinson's disease based on UK Brain Bank diagnostic criteria
- Parkinson's disease with mild cognitive impairment (PD-MCI) diagnosis per Movement Disorders Society Task Force Level II Diagnostic Criteria4 (i.e., scores ≥1.5 standard deviations below appropriate norms on 2 neuropsychological tests) as determined by a clinical neuropsychologist
- Stable on Parkinson's disease medications for 30 days (not expected to change through the course of the treatment)
- Has a caregiver willing and able to reliably complete a questionnaire focused on the participant's daily functioning
Who cannot join
- Claustrophobia or inability to lie supine in the scanner for an extended period of time
- Barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed)
- Contraindications to MRI/TMS safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, non-removable hair clips or piercings, and medications that reduce seizure threshold.
- Individuals with a diagnosis of bipolar disorder, schizophrenia, and/or active substance abuse disorder.
- History of significant or unstable condition/s or treatments for these condition/s that may impact cognition (as determined by the study investigators) such as significant cardiac (e.g. heart failure), infectious (e.g. HIV, urinary tract infection), or metabolic disease (e.g. labile diabetes), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. multiple sclerosis, moderate to severe brain injury, seizures).
- History of a seizure disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Sam Crowley, PhD, 843-792-7767, crowleys@musc.edu
About this study
Official title: Accelerated Intermittent Theta Burst Stimulation for Mild Cognitive Impairment in Parkinson's Disease
The goal of this study is to determine the whether a short-term, high-dose form of non-invasive brain stimulation (intermittent theta burst stimulation; iTBS) is a promising and safe treatment for mild cognitive impairment in Parkinson's disease (PD-MCI).
Read the detailed description
Dementia occurs in 80% of people with Parkinson's disease (PD) within 20 years of diagnosis. Cognitive interventions in PD have centered on individuals with mild cognitive impairment (PD-MCI). A lack of efficacy of pharmacological interventions in PD-MCI has driven interest in nonpharmacological approaches. The most promising of these is intermittent theta burst stimulation (iTBS), a noninvasive brain stimulation method that is FDA-approved for several psychiatric conditions. Though iTBS has shown little to no benefit in PD-MCI thus far, there are modifiable issues with past interventions including exclusively targeting prefrontal cortex when cholinergic denervation in posterior cortex is strongly associated with cognitive decline in PD, and substantial underdosing compared to efficacious iTBS interventions (6,000 vs at least 18,000 pulses). Interventions will likely have better outcomes if they target the right superior parietal lobule (rSPL), a cortical region impacted by cholinergic denervation in PD that is essential to maintaining attention, and use accelerated iTBS (a-iTBS) to deliver a stimulation dose commensurate with FDA-approved protocols in a shorter timeframe. However, before the efficacy of such an intervention can be evaluated, it must be established as safe, tolerable and feasible in PD-MCI. This project therefore aims to evaluate the safety, tolerability and feasibility of a three-day a-iTBS intervention stimulating the rSPL with 18,000 total pulses.
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Being tested
- Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL)
- Keywords
- Transcranial Magnetic Stimulation, Theta Burst Stimulation, Parkinson's Disease, Cognitive Impairment, Neuromodulation
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL)Device
Participants in this single-arm study will receive a accelerated course of intermittent theta burst stimulation (iTBS) over superior parietal lobule, which is identified with MNI coordinates from past studies. The stimulation will be delivered using a MagVenture MagPro TMS System with a butterfly, active cooling coil at 120% of resting motor threshold.
Each participant will complete 3 consecutive treatment days, undergoing10 rTMS sessions per day (600 pulses/session), totaling 18,000 pulses across the study. Safety, tolerability, adherence, and feasibility data will be collected for the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated iTBS | Experimental | Participants will undergo accelerated intermittent theta burst stimulation (iTBS) targeting the right superior parietal lobule (rSPL) using a MagVenture MagPro system with a cooled butterfly coil, with Brainsight neuronavigation identifying the stimulation site. Resting motor threshold (rMT) will be determined on the first stimulation visit using Parameter Estimation by Sequential Testing (PEST). Stimulation for the intervention will be delivered at 120% rMT. Stimulation sessions will occur over three consecutive days. Each day will include 10 sessions separated by 10-15 min. Each session delivers 600 pulses (50 Hz triplets; 2 s on/8 s off; ~190 seconds), totaling 6,000 pulses/day and 18,000 pulses overall. Coil position/angle and scalp-to-cortex distance are tracked; tolerability/acceptability (headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) will be assessed before and after sessions. Receives: Device: Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
Number of serious adverse events experienced by study participants caused by the iTBS protocol
Measured: Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3
Feasibility of the study protocol
Feasibility will be defined as the proportion of participants enrolled that complete all intervention procedures
Measured: Week 0 through completion of study (8 weeks)
Tolerability of TMS procedures
A questionnaire evaluating the presence and severity of commonly experienced side effects of TMS (i.e. headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) within the past 24 hours and during stimulation. Ratings will be on a 6-point Likert scale from 0 (no symptoms) to 5 (severe symptoms).
Measured: Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3
Test-retest reliability of the Continuous Temporal Expectancy Test (CTET)
The CTET is a tablet-administered measure designed to assess sustained attention and distractibility. Participants will be shown a grid with black and white squares on a tablet that rotate after either a longer duration (target stimulus; 1070ms) or a shorter duration (non-target stimulus; 800ms) and must press the screen when they identify a target stimulus. Participants will complete 10 one-minute trials. Half of the trials are performed without a distractor present, and the other half are performed with an audio-video distractor presented on an adjacent laptop screen. The primary outcome is the distractibility score, defined as the difference in latency (in ms) to identifying the target stimulus between distractor and non-distractor trials.
Measured: Week 0 (4 weeks pre-intervention) to Week 4, Day 1 (30 minutes prior to intervention)
Secondary outcomes (6)
Change in Continuous Temporal Expectancy Task (CTET) Distractibility Score
Change in CTET Distractibility Score ([distraction trial latency in ms] - [non-distraction trial latency in ms]). Higher scores indicate worse performance.
Measured: Week 4, Day 1 (30 minutes prior to intervention) to Week 4, Day 3 (15 minutes after intervention) to Week 8 (4 weeks post-intervention)
Change in NIH Toolbox Cognitive Battery (NIHTB-CB) Composite Scores
The NIHTB-CB is a performance-based, iPad-administered suite of 7 tests that ascertain abilities in different cognitive domains (i.e. executive function, episodic memory, working memory, processing speed, language). It was developed using advanced psychometric techniques to minimize measurement error and produces normed subtest and composite scores. We will use the fully-corrected T-score (range T=0-100; Mean T=50, SD=10; higher scores indicating better cognition) of the Fluid Cognition Composite and Crystallized Cognition Composite, which are normed for age, sex, years of education, and race/ethnicity.
Measured: Week 4, Day 1 (30 minutes prior to intervention intervention) to Week 4, Day 3 (15 minutes after intervention) to Week 8 (4 weeks post-intervention)
Change in daily functioning
Change in caregiver ratings on the ECog-12, a questionnaire designed to measure the participant's everyday cognition and functional decline based on 12 Likert scale items ranging from 1 (no change compared to 10 years earlier) to 4 (consistently much worse).
Measured: Week 0 (1 month pre-intervention) to Week 8 (1 month post-intervention)
Change in Beck Depression Inventory II (BDI-II) Raw Score
The Beck Depression Inventory II (BDI-II) is a self-report measure of depressive symptoms comprised of 21 questions rated on a Likert scale from 0 (least severe) to 3 (most severe).
Measured: Week 4, Day 1 (pre-intervention) to Week 8 (1 month post-intervention)
Change in Beck Anxiety Inventory (BAI) Score
The Beck Anxiety Inventory (BAI) is a self-report measure of depressive symptoms comprised of 21 questions rated on a Likert scale from 0 (least severe) to 3 (most severe).
Measured: Week 1, Day 1 (pre-intervention) to Week 8 (one-month follow-up)
Change in Apathy Evaluation Scale (AES) Raw Score
The Apathy Evaluation Scale is a self-report measure of apathy symptoms comprised of 18 Likert scale items rated from 0 (least severe) to 3 (most severe).
Measured: Week 4, Day 1 (pre-intervention) to Week 8 (1-month post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start9 Oct 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Sam Crowley, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701785
- Sponsor's protocol ID
- Pro00151225
- Other IDs
- K12TR005297
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Demographic information on trial participants and data acquired throughout the trial will be shared upon request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Intermittent Theta Burst Stimulation for Mild Cognitive Impairment in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07701785
- Acronym / sponsor ID
- Pro00151225
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Keywords
- Transcranial Magnetic Stimulation, Theta Burst Stimulation, Parkinson's Disease, Cognitive Impairment, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 9 Oct 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine the whether a short-term, high-dose form of non-invasive brain stimulation (intermittent theta burst stimulation; iTBS) is a promising and safe treatment for mild cognitive impairment in Parkinson's disease (PD-MCI).
Detailed description
Dementia occurs in 80% of people with Parkinson's disease (PD) within 20 years of diagnosis. Cognitive interventions in PD have centered on individuals with mild cognitive impairment (PD-MCI). A lack of efficacy of pharmacological interventions in PD-MCI has driven interest in nonpharmacological approaches. The most promising of these is intermittent theta burst stimulation (iTBS), a noninvasive brain stimulation method that is FDA-approved for several psychiatric conditions. Though iTBS has shown little to no benefit in PD-MCI thus far, there are modifiable issues with past interventions including exclusively targeting prefrontal cortex when cholinergic denervation in posterior cortex is strongly associated with cognitive decline in PD, and substantial underdosing compared to efficacious iTBS interventions (6,000 vs at least 18,000 pulses). Interventions will likely have better outcomes if they target the right superior parietal lobule (rSPL), a cortical region impacted by cholinergic denervation in PD that is essential to maintaining attention, and use accelerated iTBS (a-iTBS) to deliver a stimulation dose commensurate with FDA-approved protocols in a shorter timeframe. However, before the efficacy of such an intervention can be evaluated, it must be established as safe, tolerable and feasible in PD-MCI. This project therefore aims to evaluate the safety, tolerability and feasibility of a three-day a-iTBS intervention stimulating the rSPL with 18,000 total pulses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accelerated iTBS | Experimental | Device: Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL)Participants will undergo accelerated intermittent theta burst stimulation (iTBS) targeting the right superior parietal lobule (rSPL) using a MagVenture MagPro system with a cooled butterfly coil, with Brainsight neuronavigation identifying the stimulation site. Resting motor threshold (rMT) will be determined on the first stimulation visit using Parameter Estimation by Sequential Testing (PEST). Stimulation for the intervention will be delivered at 120% rMT. Stimulation sessions will occur over three consecutive days. Each day will include 10 sessions separated by 10-15 min. Each session delivers 600 pulses (50 Hz triplets; 2 s on/8 s off; ~190 seconds), totaling 6,000 pulses/day and 18,000 pulses overall. Coil position/angle and scalp-to-cortex distance are tracked; tolerability/acceptability (headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) will be assessed before and after sessions. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50-85 years of age
- Diagnosis of Parkinson's disease based on UK Brain Bank diagnostic criteria
- Parkinson's disease with mild cognitive impairment (PD-MCI) diagnosis per Movement Disorders Society Task Force Level II Diagnostic Criteria4 (i.e., scores ≥1.5 standard deviations below appropriate norms on 2 neuropsychological tests) as determined by a clinical neuropsychologist
- Stable on Parkinson's disease medications for 30 days (not expected to change through the course of the treatment)
- Has a caregiver willing and able to reliably complete a questionnaire focused on the participant's daily functioning
Key exclusion criteria (6 listed)
- Claustrophobia or inability to lie supine in the scanner for an extended period of time
- Barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed)
- Contraindications to MRI/TMS safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, non-removable hair clips or piercings, and medications that reduce seizure threshold.
- Individuals with a diagnosis of bipolar disorder, schizophrenia, and/or active substance abuse disorder.
- History of significant or unstable condition/s or treatments for these condition/s that may impact cognition (as determined by the study investigators) such as significant cardiac (e.g. heart failure), infectious (e.g. HIV, urinary tract infection), or metabolic disease (e.g. labile diabetes), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. multiple sclerosis, moderate to severe brain injury, seizures).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL)Participants in this single-arm study will receive a accelerated course of intermittent theta burst stimulation (iTBS) over superior parietal lobule, which is identified with MNI coordinates from past studies. The stimulation will be delivered using a MagVenture MagPro TMS System with a butterfly, active cooling coil at 120% of resting motor threshold. Each participant will complete 3 consecutive treatment days, undergoing10 rTMS sessions per day (600 pulses/session), totaling 18,000 pulses across the study. Safety, tolerability, adherence, and feasibility data will be collected for the intervention. | Device | Accelerated iTBS |
Primary outcome
Serious Adverse Events
Time frame: Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3
Number of serious adverse events experienced by study participants caused by the iTBS protocol
Feasibility of the study protocol
Time frame: Week 0 through completion of study (8 weeks)
Feasibility will be defined as the proportion of participants enrolled that complete all intervention procedures
Tolerability of TMS procedures
Time frame: Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3
A questionnaire evaluating the presence and severity of commonly experienced side effects of TMS (i.e. headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) within the past 24 hours and during stimulation. Ratings will be on a 6-point Likert scale from 0 (no symptoms) to 5 (severe symptoms).
Test-retest reliability of the Continuous Temporal Expectancy Test (CTET)
Time frame: Week 0 (4 weeks pre-intervention) to Week 4, Day 1 (30 minutes prior to intervention)
The CTET is a tablet-administered measure designed to assess sustained attention and distractibility. Participants will be shown a grid with black and white squares on a tablet that rotate after either a longer duration (target stimulus; 1070ms) or a shorter duration (non-target stimulus; 800ms) and must press the screen when they identify a target stimulus. Participants will complete 10 one-minute trials. Half of the trials are performed without a distractor present, and the other half are performed with an audio-video distractor presented on an adjacent laptop screen. The primary outcome is the distractibility score, defined as the difference in latency (in ms) to identifying the target stimulus between distractor and non-distractor trials.
6 secondary outcomes
Change in Continuous Temporal Expectancy Task (CTET) Distractibility Score
Time frame: Week 4, Day 1 (30 minutes prior to intervention) to Week 4, Day 3 (15 minutes after intervention) to Week 8 (4 weeks post-intervention)
Change in NIH Toolbox Cognitive Battery (NIHTB-CB) Composite Scores
Time frame: Week 4, Day 1 (30 minutes prior to intervention intervention) to Week 4, Day 3 (15 minutes after intervention) to Week 8 (4 weeks post-intervention)
Change in daily functioning
Time frame: Week 0 (1 month pre-intervention) to Week 8 (1 month post-intervention)
Change in Beck Depression Inventory II (BDI-II) Raw Score
Time frame: Week 4, Day 1 (pre-intervention) to Week 8 (1 month post-intervention)
Change in Beck Anxiety Inventory (BAI) Score
Time frame: Week 1, Day 1 (pre-intervention) to Week 8 (one-month follow-up)
Change in Apathy Evaluation Scale (AES) Raw Score
Time frame: Week 4, Day 1 (pre-intervention) to Week 8 (1-month post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes. Demographic information on trial participants and data acquired throughout the trial will be shared upon request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL) in people with Parkinson Disease and Mild Cognitive Impairment, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.