Progressive Supranuclear PalsyDeepTMSPARKNCT02734485
Deep TMS for the Treatment of Patients With Parkinson's Disease and Progressive Supranuclear Palsy
A study testing active Deep TMS in people with Progressive Supranuclear Palsy and Parkinson's Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
Background: Progressive supranuclear palsy (PSP) is a rare neuro-degenerative disease, counted among atypical parkinsonism (AP). Medical treatment and rehabilitation are extremely limited in AP, therefore it would be very useful to find new ways to improve motor and non motor symptoms in PSP. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Progressive Supranuclear Palsy, Parkinson's Disease
- What is being tested?
- active Deep TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatients with PSP according to NINDS-SPSP criteria
Who cannot join
- contraindications for DTMS (history of seizures, pacemakers, or any other electric device)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Deep TMS for the Treatment and Rehabilitation of Patients With Parkinson's Disease and Progressive Supranuclear Palsy
Background: Progressive supranuclear palsy (PSP) is a rare neuro-degenerative disease, counted among atypical parkinsonism (AP). Medical treatment and rehabilitation are extremely limited in AP, therefore it would be very useful to find new ways to improve motor and non motor symptoms in PSP. The Brainway Deep Transcranial magnetic stimulation (DTMS) is a new technology of TMS using a particular coil, i.e. H-coil, able to stimulate deeper regions of the brain. Only few studies in literature have evaluated the efficacy of DTMS in Parkinson's Disease and parkinsonism; in particular in PSP patients, a case report showed an improvement in language.
Read the detailed description
Materials and Methods: This study was a pilot, randomized, cross-over, double blind trial. It was designed to evaluate the efficacy of Deep TMS in terms of recovery of motor functions, freezing of gait, and cognitive decline in patients with PSP. Nineteen subject underwent 14 session of high frequency DTMS over a 4 weeks period. The target were the left Broca and dorsolateral prefrontal cortex.
- Being tested
- active Deep TMS, sham Deep TMS
- Keywords
- Progressive supranuclear palsy, Deep transcranial magnetic stimulation
- Medical subject headings
- Supranuclear Palsy, Progressive, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active Deep TMSDevice
The Brainsway DTMS produces a time-varying magnetic field and, based on Faraday's Law, it can be assumed that a time-varying magnetic field generates an electrical current in a nearby conductive substance. The induced electric current in the cortex travels in an orthogonal path in the direction of the magnetic field with the maximum strength and current located beneath the coil in the helmet placed on the patient's head and transmits magnetic pulses to the patient's brain. The induced current is tangential to the scalp at the cortical surface, and decreases in magnitude with increasing depth.
Patients underwent 12 sessions, 3 times a week, of repetitive DTMS using the novel H2-coil (Brainsway LDT).
sham Deep TMSDevice
The Sham DTMS consisted in the same protocol of active treatment with the same preparation of the subject and settings of the instrument but with an INACTIVE DTMS coil.
| Study group | Role | What they receive |
|---|---|---|
| active Deep Tms | Active comparator | Each DTMS session consisted in two consecutive stimulations: a first low-frequency (1 Hz) stimulation in the motor cortex (110% of the motor threshold, for 15 minutes)and a second high-frequency (10Hz) one in the prefrontal cortex (100% motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes).The coil contains two symmetric devices, perfectly designed to rouse both hemispheres at the same time. Receives: Device: active Deep TMS |
| sham deep tms | Sham comparator | The Sham DTMS consisted in the same protocol of active treatment with the same preparation of the subject and settings of the instrument but with an inactive DTMS coil. Receives: Device: sham Deep TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PSP rating scale total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
Clinical measures were summarized as means and standard deviations for all the 19 patients and stratified by treatment (active and sham) and evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation: T1 for first period, T3 for second period).
Measured: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period).
Secondary outcomes (4)
Change in MoCA total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
Clinical measures were summarized as means and standard deviations for all the 19 patients and stratified by treatment (active and sham) and evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation: T1 for first period, T3 for second period).
Measured: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period
Change in PDQ 39 total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
Clinical measures were summarized as means and standard deviations for all the 19 patients and stratified by treatment (active and sham) and evaluation time
Measured: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period
Change in NMS total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
Clinical measures were summarized as means and standard deviations for all the 19 patients and stratified by treatment (active and sham) and evaluation time
Measured: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period
Change in Hamilton rating scale for depression total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
Clinical measures were summarized as means and standard deviations for all the 19 patients and stratified by treatment (active and sham) and evaluation time
Measured: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Progressive Supranuclear PalsyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrizio Stocchi, MD, PHD, Principal investigator, IRCCS SAN RAFFAELE PISANA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734485
- Sponsor's protocol ID
- RP 16/13
- Acronym
- DeepTMSPARK
- Status last verified
- Jun 2023
- First submitted
- 31 Mar 2016
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Boeve BF. Progressive supranuclear palsy. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1:S192-4. doi: 10.1016/S1353-8020(11)70060-8.
PubMed 22166432Levkovitz Y, Roth Y, Harel EV, Braw Y, Sheer A, Zangen A. A randomized controlled feasibility and safety study of deep transcranial magnetic stimulation. Clin Neurophysiol. 2007 Dec;118(12):2730-44. doi: 10.1016/j.clinph.2007.09.061. Epub 2007 Oct 30.
PubMed 17977787Trebbastoni A, Raccah R, de Lena C, Zangen A, Inghilleri M. Repetitive deep transcranial magnetic stimulation improves verbal fluency and written language in a patient with primary progressive aphasia-logopenic variant (LPPA). Brain Stimul. 2013 Jul;6(4):545-53. doi: 10.1016/j.brs.2012.09.014. Epub 2012 Oct 24.
PubMed 23122915Radicati FG, Vacca L, Casali M, Tremigliozzi I, Alborghetti M, Lombardi M, Rossini PM, Stocchi F. Deep transcranial magnetic stimulation in progressive supranuclear palsy: a randomized double-blind, cross-over study. Neurol Sci. 2025 Dec;46(12):6923-6931. doi: 10.1007/s10072-025-08549-1. Epub 2025 Nov 12.
PubMed 41219570
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Deep TMS for the Treatment and Rehabilitation of Patients With Parkinson's Disease and Progressive Supranuclear Palsy
- ClinicalTrials.gov ID
- NCT02734485
- Acronym / sponsor ID
- DeepTMSPARK / RP 16/13
- Keywords
- Progressive supranuclear palsy, Deep transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Apr 2016 (estimated)
- 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.
Background: Progressive supranuclear palsy (PSP) is a rare neuro-degenerative disease, counted among atypical parkinsonism (AP). Medical treatment and rehabilitation are extremely limited in AP, therefore it would be very useful to find new ways to improve motor and non motor symptoms in PSP. The Brainway Deep Transcranial magnetic stimulation (DTMS) is a new technology of TMS using a particular coil, i.e. H-coil, able to stimulate deeper regions of the brain. Only few studies in literature have evaluated the efficacy of DTMS in Parkinson's Disease and parkinsonism; in particular in PSP patients, a case report showed an improvement in language.
Detailed description
Materials and Methods: This study was a pilot, randomized, cross-over, double blind trial. It was designed to evaluate the efficacy of Deep TMS in terms of recovery of motor functions, freezing of gait, and cognitive decline in patients with PSP. Nineteen subject underwent 14 session of high frequency DTMS over a 4 weeks period. The target were the left Broca and dorsolateral prefrontal cortex.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active Deep Tms | Active comparator | Device: active Deep TMSEach DTMS session consisted in two consecutive stimulations: a first low-frequency (1 Hz) stimulation in the motor cortex (110% of the motor threshold, for 15 minutes)and a second high-frequency (10Hz) one in the prefrontal cortex (100% motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes).The coil contains two symmetric devices, perfectly designed to rouse both hemispheres at the same time. |
| sham deep tms | Sham comparator | Device: sham Deep TMSThe Sham DTMS consisted in the same protocol of active treatment with the same preparation of the subject and settings of the instrument but with an inactive DTMS coil. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- outpatients with PSP according to NINDS-SPSP criteria
Key exclusion criteria (1 listed)
- contraindications for DTMS (history of seizures, pacemakers, or any other electric device)
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 |
|---|---|---|
| active Deep TMSThe Brainsway DTMS produces a time-varying magnetic field and, based on Faraday's Law, it can be assumed that a time-varying magnetic field generates an electrical current in a nearby conductive substance. The induced electric current in the cortex travels in an orthogonal path in the direction of the magnetic field with the maximum strength and current located beneath the coil in the helmet placed on the patient's head and transmits magnetic pulses to the patient's brain. The induced current is tangential to the scalp at the cortical surface, and decreases in magnitude with increasing depth. Patients underwent 12 sessions, 3 times a week, of repetitive DTMS using the novel H2-coil (Brainsway LDT). | Device | active Deep Tms |
| sham Deep TMSThe Sham DTMS consisted in the same protocol of active treatment with the same preparation of the subject and settings of the instrument but with an INACTIVE DTMS coil. | Device | sham deep tms |
Primary outcome
Change in PSP rating scale total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
Time frame: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period).
Clinical measures were summarized as means and standard deviations for all the 19 patients and stratified by treatment (active and sham) and evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation: T1 for first period, T3 for second period).
4 secondary outcomes
Change in MoCA total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
Time frame: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period
Change in PDQ 39 total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
Time frame: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period
Change in NMS total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
Time frame: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period
Change in Hamilton rating scale for depression total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3)
Time frame: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Background: PubMed 22166432Boeve BF. Progressive supranuclear palsy. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1:S192-4. doi: 10.1016/S1353-8020(11)70060-8.
- Background: PubMed 17977787Levkovitz Y, Roth Y, Harel EV, Braw Y, Sheer A, Zangen A. A randomized controlled feasibility and safety study of deep transcranial magnetic stimulation. Clin Neurophysiol. 2007 Dec;118(12):2730-44. doi: 10.1016/j.clinph.2007.09.061. Epub 2007 Oct 30.
- Background: PubMed 23122915Trebbastoni A, Raccah R, de Lena C, Zangen A, Inghilleri M. Repetitive deep transcranial magnetic stimulation improves verbal fluency and written language in a patient with primary progressive aphasia-logopenic variant (LPPA). Brain Stimul. 2013 Jul;6(4):545-53. doi: 10.1016/j.brs.2012.09.014. Epub 2012 Oct 24.
- Derived from this study: PubMed 41219570Radicati FG, Vacca L, Casali M, Tremigliozzi I, Alborghetti M, Lombardi M, Rossini PM, Stocchi F. Deep transcranial magnetic stimulation in progressive supranuclear palsy: a randomized double-blind, cross-over study. Neurol Sci. 2025 Dec;46(12):6923-6931. doi: 10.1007/s10072-025-08549-1. Epub 2025 Nov 12.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Fabrizio Stocchi, MD, PHD principal investigator
IRCCS SAN RAFFAELE PISANA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active Deep TMS in people with Progressive Supranuclear Palsy and Parkinson's Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Jun 2023. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PSP rating scale total score between baseline evaluations (T0 orT2) and end of treatment (T1 or T3) (time frame: evaluation time (pre-stimulation: T0 for first period, T2 for second period; post-stimulation (after four weeks of treatment): T1 for first period, T3 for second period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02734485, which also lists 4 linked publications.
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 26 Jun 2023.