Superior Parietal iTBS for PD-MCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorMedical University of South Carolina
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL)
DeviceParticipants 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Accelerated iTBSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Serious Adverse Events
Number of serious adverse events experienced by study participants caused by the iTBS protocol
Time frame
Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-32
Feasibility of the study protocol
Feasibility will be defined as the proportion of participants enrolled that complete all intervention procedures
Time frame
Week 0 through completion of study (8 weeks)3
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).
Time frame
Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-34
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.
Time frame
Week 0 (4 weeks pre-intervention) to Week 4, Day 1 (30 minutes prior to intervention)Secondary outcomes
1
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.
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)2
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.
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)3
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).
Time frame
Week 0 (1 month pre-intervention) to Week 8 (1 month post-intervention)4
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).
Time frame
Week 4, Day 1 (pre-intervention) to Week 8 (1 month post-intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Source ClinicalTrials.gov