Effects of Accelerated rTMS On Motor and Cognitive Function in Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorSan Francisco Neurology and Sleep Center
About this trial
Parkinson's disease (PD) is a brain disorder that causes progressive problems with movement, such as slowness, stiffness, tremor, and difficulty walking. Many people with PD also develop problems with thinking and memory. Current medications can help control movement symptoms but often become less effective over time and may cause side effects. There is a need for additional treatment options that can address both movement and thinking difficulties in PD.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment that uses magnetic pulses delivered to the scalp to stimulate specific areas of the brain. Previous research has shown that rTMS targeting the motor cortex (the part of the brain that controls movement) can improve motor symptoms in people with PD.
The purpose of this pilot study is to evaluate whether an accelerated course of rTMS targeting the motor cortex can improve movement and thinking abilities in people with mild to moderate Parkinson's disease. The study will enroll 40 participants aged 50 to 90 years at the San Francisco Neurology and Sleep Center.
Participants will receive 6 sessions of rTMS using the EXOMIND™ device, administered twice per week over approximately 3 weeks. Each session delivers high-frequency magnetic stimulation to the motor cortex on both sides of the brain. Participants will be assessed before treatment, at the last treatment session, and at 1-month and 3-month follow-up visits.
The primary outcome measure is the change in motor symptoms as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) at 1 month after treatment. Secondary outcomes include additional measures of walking and gait, domain-specific cognitive testing using the Creyos cognitive battery (assessing memory, attention, reasoning, and other thinking skills), the Montreal Cognitive Assessment (MoCA), depression symptoms (PHQ-9), and quality of life (PDQ-39).
This is a single-center, open-label study with no placebo or control group. Total participation duration is up to 139 days, including screening, treatment, and follow-up visits.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must be 50 to 90 years of age, inclusive, on the day of signing informed consent.
Diagnosis of idiopathic Parkinson's disease according to the Movement Disorder Society Clinical Diagnostic Criteria or UK Parkinson's Disease Society Brain Bank criteria.
Hoehn and Yahr stage 1-3 (mild to moderate disease severity).
MDS-UPDRS-III (Motor Examination) score ≥10 at screening.
Disqualifiers
Electronic implants in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants in or near the head including device leads, deep brain stimulators, cochlear implants, ocular implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators.
Metallic, ferromagnetic, or other magnetic-sensitive implants/objects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic, or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth - see Operator's Manual) or within 12 inches (30 cm) of the therapy coil. Examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry, hair barrettes, and tattoos with metallic ink.
Drug pumps within 12 inches (30 cm) of the therapy coil.
Inability to determine the motor threshold of the participant (i.e., the minimum stimulus required to induce contraction of the contralateral hand muscles cannot be established).
Trial design
Design model
Single group
Treatments tested in this trial
TMS
DeviceThe open-label treatment phase will consist of 6 sessions of rTMS using the EXOMIND™ device (BTL-699-2), administered twice a week over approximately 3 weeks. Each session will deliver high-frequency stimulation (10-20 Hz) at 90-110% of resting motor threshold (RMT), with 3,000-6,000 total pulses per session. The target site will be the primary motor cortex (M1), with bilateral stimulation. The motor cortex will be localized using the standard motor threshold determination procedure, identifying the scalp position that produces consistent contraction of the contralateral hand muscles. The procedure will be conducted at San Francisco Neurology and Sleep Center with medical staff support.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: rTMS TreatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) score at 1-month follow-up
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) is a clinician-rated assessment of motor function in Parkinson's disease. It evaluates 18 items across motor domains including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, body bradykinesia, postural tremor, kinetic tremor, rest tremor amplitude, and constancy of rest tremor. Each item is scored from 0 (normal) to 4 (severe), yielding a total score range of 0 to 132, with higher scores indicating greater motor impairment. Change from baseline is calculated as the 1-month follow-up score minus the baseline score, with negative values indicating improvement.
Time frame
From baseline to the 1-month follow upSecondary outcomes
1
Change from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) score at the last treatment session
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) is a clinician-rated assessment of motor function in Parkinson's disease. It evaluates 18 items across motor domains including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, body bradykinesia, postural tremor, kinetic tremor, rest tremor amplitude, and constancy of rest tremor. Each item is scored from 0 (normal) to 4 (severe), yielding a total score range of 0 to 132, with higher scores indicating greater motor impairment. Change from baseline is calculated as the last treatment session score minus the baseline score, with negative values indicating improvement.
Time frame
From baseline to the end of treatment (approximately Day 21)2
Change from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) score at 3-month follow-up
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) is a clinician-rated assessment of motor function in Parkinson's disease. It evaluates 18 items across motor domains including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, body bradykinesia, postural tremor, kinetic tremor, rest tremor amplitude, and constancy of rest tremor. Each item is scored from 0 (normal) to 4 (severe), yielding a total score range of 0 to 132, with higher scores indicating greater motor impairment. Change from baseline is calculated as the 3-month follow-up score minus the baseline score, with negative values indicating improvement.
Time frame
From baseline to the end of treatment at 3-month follow-up3
Change from baseline in the Montreal Cognitive Assessment (MoCA) score at 1-month follow-up
The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Total Score Range: 0 to 30. Interpretation: Higher scores indicate better cognitive function (a score of 26 or above is generally considered normal). Metric: The change is calculated by subtracting the baseline score from the 1-month follow-up score.
Time frame
From baseline to the 1-month follow up4
Change from baseline in the Montreal Cognitive Assessment (MoCA) score at the last treatment session
The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Total Score Range: 0 to 30. Interpretation: Higher scores indicate better cognitive function (a score of 26 or above is generally considered normal). Metric: The change is calculated by subtracting the baseline score from the last treatment score.
Time frame
From baseline to the end of treatment (approximately Day 21)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov