rTMS for Progressive Supranuclear Palsy
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Oregon Health and Science University
Must be taking: Cholinergic, Dopaminergic, Serotonergic, NMDA antagonists
Disqualifiers: Neurological disorders, Vestibular disorders, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?The objective of this proposal is to investigate the effect of non-invasive repetitive cerebellar transcranial magnetic stimulation (rTMS) on motor control in progressive supranuclear (PSP). The central hypothesis is that augmenting cerebellar inhibition via cerebellar rTMS will decrease postural instability in patients with PSP. We will use functional near infrared spectroscopy (fNIRS) to examine changes in motor and premotor cortical activity after cerebellar rTMS.
Will I have to stop taking my current medications?
You can stay on your current medications as long as the doses are stable and they are cholinergic, dopaminergic, serotonergic sedatives, or NMDA receptor antagonists.
What data supports the effectiveness of the treatment Repetitive Transcranial Magnetic Stimulation (rTMS) for Progressive Supranuclear Palsy?
Research shows that rTMS can lead to modest and temporary improvements in symptoms for patients with Progressive Supranuclear Palsy, particularly in balance and stability. Additionally, rTMS has been effective in improving language functions in other neurodegenerative conditions, suggesting potential benefits for similar disorders.
12345Is repetitive transcranial magnetic stimulation (rTMS) generally safe for humans?
Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe, with guidelines established to minimize risks. Some studies report a slight risk of seizures and other adverse effects, but these are rare. Safety guidelines have been updated over the years to ensure safe application in both healthy individuals and those with various conditions.
678910How does the treatment rTMS differ from other treatments for Progressive Supranuclear Palsy?
Repetitive transcranial magnetic stimulation (rTMS) is unique because it is a non-invasive treatment that uses magnetic fields to stimulate nerve cells in the brain, which is different from traditional drug therapies. It has shown modest and temporary improvements in symptoms of Progressive Supranuclear Palsy, a condition for which no specific treatments currently exist.
134511Eligibility Criteria
This trial is for adults aged 40-85 with progressive supranuclear palsy (PSP) who can follow simple instructions and walk independently with a walker. They must not start new therapies during the study, be on stable medication doses, and women of childbearing age need to use reliable birth control.Inclusion Criteria
Ability to read at 6th grade reading level in English
I can keep my current doses of brain-related medications stable during the study.
I can avoid starting new physical or speech therapy during the study.
+5 more
Exclusion Criteria
I do not have major nerve or balance disorders.
You have any electronic, magnetic, or mechanical implants, or have had metal in your eyes, head, or body that could cause harm.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Participants undergo baseline assessments before starting the intervention
1 week
TMS Intervention
Participants receive a 2-week TMS intervention or sham treatment
2 weeks
4 visits (in-person)
Washout Period
A 1-month washout period between TMS and sham treatments
4 weeks
Sham TMS or TMS Intervention
Participants receive a 2-week sham TMS or TMS intervention
2 weeks
4 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial tests if non-invasive brain stimulation called repetitive transcranial magnetic stimulation (rTMS) can improve motor control in PSP patients by targeting the cerebellum. Changes in brain activity will be monitored using functional near infrared spectroscopy (fNIRS).
2Treatment groups
Experimental Treatment
Group I: Sham treatment firstExperimental Treatment1 Intervention
After completing their baseline assessment, participants randomized to this arm will initially take part in a 2-week sham TMS period. After the midpoint assessment and subsequent a 1-month washout, these participants will then complete a 2-week TMS intervention prior to their final assessment.
Group II: Active TMS firstExperimental Treatment1 Intervention
After completing their baseline assessment, participants randomized to this arm will initially take part in a 2-week TMS intervention. After the midpoint assessment and subsequent a 1-month washout, these participants will then complete a 2-week sham TMS period prior to their final assessment.
Repetitive transcranial magnetic stimulation (rTMS) is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as rTMS for:
- Major depressive disorder
- Obsessive-compulsive disorder
- Migraine prevention
🇪🇺 Approved in European Union as rTMS for:
- Major depressive disorder
- Obsessive-compulsive disorder
🇨🇦 Approved in Canada as rTMS for:
- Major depressive disorder
- Obsessive-compulsive disorder
🇦🇺 Approved in Australia as rTMS for:
- Major depressive disorder
- Obsessive-compulsive disorder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Oregon Health & Science UniversityPortland, OR
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Who Is Running the Clinical Trial?
Oregon Health and Science UniversityLead Sponsor
National Center of Neuromodulation for RehabilitationCollaborator
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
Collins Medical TrustCollaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
National Institutes of Health (NIH)Collaborator
Department of Health and Human ServicesCollaborator
National Center for Advancing Translational Sciences (NCATS)Collaborator
National Center of Neuromodulation for Rehabilitation (NC-NM4R)Collaborator
References
Repetitive transcranial magnetic stimulation in patients with progressive supranuclear palsy: a pilot study. [2009]Progressive supranuclear palsy is a progressive neurodegenerative disorder for which no specific treatment is known at present. In this report we treated a small group of clinically diagnosed patients with rapid-rate repetitive transcranial magnetic stimulation of the motor cortex for five days. This resulted in modest and transient improvements, especially of the axial symptomatology. Side-effects were not reported.
A case study of Primary Progressive Aphasia: improvement on verbs after rTMS treatment. [2022]This case-report shows that high frequency repetitive Transcranial Magnetic Stimulation (hf-rTMS), applied to the left prefrontal cortex, may improve the linguistic skills in Primary Progressive Aphasia (PPA). The patient's performance was evaluated on a battery of language production and memory span tasks, before and after two hf-rTMS treatments and one SHAM treatment. We observed a significant and lasting improvement of the patient's performance on verb production following the application of hf-rTMS versus Baseline and SHAM conditions. This finding suggests that hf-rTMS may directly strengthen the neural connections within an area of metabolic dysfunction and encourages the use of rTMS as an alternative therapeutic tool for neurodegenerative forms of aphasia.
Cerebellar rTMS in PSP: a Double-Blind Sham-Controlled Study Using Mobile Health Technology. [2022]There are no effective treatments in progressive supranuclear palsy (PSP). The aim of this study was to test the efficacy of theta burst repetitive transcranial magnetic stimulation (rTMS) on postural instability in PSP. Twenty PSP patients underwent a session of sham or real cerebellar rTMS in a crossover design. Before and after stimulation, static balance was evaluated with instrumented (lower back accelerometer, Rehagait®, Hasomed, Germany) 30-s trials in semitandem and tandem positions. In tandem and semitandem tasks, active stimulation was associated with increase in time without falls (both p=0.04). In the same tasks, device-extracted parameters revealed significant improvement in area (p=0.007), velocity (p=0.005), acceleration and jerkiness of sway (p=0.008) in real versus sham stimulation. Cerebellar rTMS showed a significant effect on stability in PSP patients, when assessed with mobile digital technology, in a double-blind design. These results should motivate larger and longer trials using non-invasive brain stimulation for PSP patients.
Treatment of primary progressive aphasia by repetitive transcranial magnetic stimulation: a randomized, double-blind, placebo-controlled study. [2023]To evaluate the efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) in patients with primary progressive aphasia (PPA). In this randomized, double-blind trial in a single center, patients who were diagnosed with PPA were randomly assigned to receive either real rTMS or sham rTMS treatment. High-frequency rTMS was delivered to the dorsolateral prefrontal cortex (DLPFC). The primary outcome was the change in Boston Naming Test (BNT) score at each follow-up compared to the baseline. The secondary outcomes included change in CAL (Communicative Activity Log) and WAB (Western Aphasia Battery) compared to baseline and neuropsychological assessments. Forty patients (16 with nonfluent, 12 with semantic and 12 with logopenic variant PPA) were enrolled and randomly assigned to the rTMS or sham rTMS group, with 20 patients in each group. Thirty-five patients (87.5%) completed a 6-month follow-up. Compared to the sham rTMS group, the BNT improvement and WAB improvement in the real rTMS group were significantly higher. These significant improvements could be observed throughout the entire 6-month follow-up. At 1 month and 3 months after treatment, CAL improvements of real rTMS were significantly higher than sham rTMS. The improvements in BNT, CAL and WAB did not significantly differ among PPA variants. No significant improvement in neuropsychological assessments was observed. High-frequency rTMS delivered to DLPFC improved language functions in patients with different PPA variants. The efficacy was still observed after 6 months of treatment. Trial registration: NCT04431401 ( https://clinicaltrials.gov/ct2/show/NCT04431401 ).
Repetitive deep transcranial magnetic stimulation improves verbal fluency and written language in a patient with primary progressive aphasia-logopenic variant (LPPA). [2022]To date, no therapies are available for the logopenic variant of primary progressive aphasia (LPPA). Even though deep repetitive transcranial magnetic stimulation (rTMS) may improve cognitive functions in some neurodegenerative disorders, no previous studies investigated its effects in patients with LPPA.
Safety of transcranial magnetic stimulation in Parkinson's disease: a review of the literature. [2021]Transcranial magnetic stimulation (TMS) has been used in both physiological studies and, more recently, the therapy of Parkinson's disease (PD). Prior TMS studies in healthy subjects and other patient populations demonstrate a slight risk of seizures and other adverse events. Our goal was to estimate these risks and document other safety concerns specific to PD patients.
Side effects of repetitive transcranial magnetic stimulation. [2005]The side effects of repetitive transcranial magnetic stimulation are largely unexplored and the limits of safe exposure have not been determined except as regards the acute production of seizures. Although tissue damage is unlikely, however, cognitive and other adverse effects have been observed and the possibility of unintended long-term changes in brain function are theoretically possible.
Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]Studies using repetitive transcranial magnetic stimulation (rTMS) in healthy individuals and those with neuropsychiatric diseases have rapidly increased since the 1990s, due to the potential of rTMS to modulate the cortical excitability in the brain depending on the stimulation parameters; therefore, the safety considerations for rTMS use are expected to become more important. Wassermann published the first safety guidelines for rTMS from the consensus conference held in 1996, and Rossi and colleague then published the second safety guidelines from the multidisciplinary consensus meeting held in Siena, Italy in 2008, on behalf of the International Federation of Clinical Neurophysiology. More than 10 years after the second guidelines, the updated third safety guidelines were recently published in 2021. The general safety guidelines for conventional rTMS have not substantially changed. Because the most frequently used rTMS protocol is conventional (low- and high-frequency) rTMS in research and clinical settings, we focus on reviewing safety issues when applying conventional rTMS with a focal cortical stimulation coil. The following issues will be covered: 1) possible adverse events induced by rTMS; 2) checklists to screen for any precautions and risks before rTMS; 3) safety considerations for dosing conventional rTMS; and 4) safety considerations for using rTMS in stroke and traumatic brain injury.
Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. [2019]The safety of repetitive transcranial magnetic stimulation (rTMS) has only previously been formally studied in volunteers receiving a single session of stimulation or in a small number of depressed subjects receiving a 2-week treatment course. This study examined safety issues in depressed subjects receiving up to 4 weeks of rTMS. Efficacy results from this study have been previously reported.
The repetitive transcranial magnetic stimulation in Alzheimer's disease patients with behavioral and psychological symptoms of dementia: a case report. [2023]Repetitive transcranial magnetic stimulation is a noninvasive intervention, can significantly reduce behavioral and psychological symptoms and cognitive impairment in AD patients. Only few cases have been reported the adverse reactions after the treatment. This report described the different adverse reactions after repetitive transcranial magnetic stimulation with different parameters.
Clinical and Electrophysiological Hints to TMS in De Novo Patients with Parkinson's Disease and Progressive Supranuclear Palsy. [2020]Transcranial magnetic stimulation (TMS) can non-invasively probe cortical excitability in movement disorders, although clinical significance is still controversial, especially at early stages. We compare single-pulse TMS in two prototypic synucleinopathy and tauopathy-i.e., Parkinson's disease (PD) and Progressive Supranuclear Palsy (PSP), respectively-to find neurophysiological differences and identify early measures associated with cognitive impairment.