Amyotrophic Lateral Sclerosis (ALS)TPS4ALSNCT06681610
Testing Pulse Stimulation to Improve Motor Function in People With ALS: A Pilot Study
A study testing Transcranial Pulse Stimulation in people with Amyotrophic Lateral Sclerosis (ALS), run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The goal of this clinical trial is to assess the efficacy of TPS of the motor cortex on biomarkers and clinical endpoints in patients with ALS. The main questions it aims to answer are: Stage 1: Is there a change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8? Stage 2: Is… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- Transcranial Pulse Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 24 Oct 2024to Dec 2026
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of sporadic ALS (definite or clinically probable) as defined by the World Federation of Neurology revised El Escorial criteria
- SVC of 50% or greater of estimated measure and presence of measurable motor evoked potential
- 21 to 80 years old and male or female
Who cannot join
- patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital del Mar
Barcelona, Catalonia, 08003
Sergio Vidal, MD, +34932 48 30 00, sergio.vidal.notari@psmar.cat
Alba Leon, MD
About this study
Official title: Modulation of the Motor Pathway by Transcranial Pulse Stimulation in People With ALS: a Pilot Randomized Trial
The goal of this clinical trial is to assess the efficacy of TPS of the motor cortex on biomarkers and clinical endpoints in patients with ALS. The main questions it aims to answer are:
- Stage 1: Is there a change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8?
- Stage 2: Is there a change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score?
In stage 2, researchers will compare the group receiving the stimulation vs the group receiving a sham stimulation to see if there is a difference in motor cortex activity and in the ALSFRS-R score
Participants will receive either:
- the TPS treatment
- a sham TPS treatment
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- Transcranial Pulse Stimulation
- Keywords
- Transcranial Pulse Stimulation (TPS), Amyotrophic Lateral Sclerosis (ALS)
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Pulse StimulationDevice
low intensity shock-waves stimulation of the motor cortex, bilateral
| Study group | Role | What they receive |
|---|---|---|
| TPS | Experimental | The stimulation will be 20 min duration as indicated in the CE mark approval. Each session involves 6,000 pulses in the hand region of the motor cortex with 3,000 on each side of the brain. The system uses a low energy flux density maximum of 0.25 mJ/mm2 accordingly with EMA and FDA guidelines (high energy is defined as > 0.5 mJ/mm2). The standard therapy involves 6 sessions in 2 weeks as indicated in the CE mark. Receives: Device: Transcranial Pulse Stimulation |
| sham | Sham comparator | The transcranial pulse stimulation with the same device and the same protocol uses a membrane on the device that blocks the sound waves. Participants' motor cortex is not stimulated. Receives: Device: Transcranial Pulse Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8.
Measured: baseline to week 8
Change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score
The ALS Functional Rating Scale-Revised Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0.
Higher scores mean a better outcome.
Measured: baseline to week 24
Secondary outcomes (8)
Change plasma neurofilament light chain (NfL) levels
Measured: baseline to week 4 and 8
Changes in muscle strength, assessed by the Medical Research Council (MRC) sum score
Measured: baseline to week 4 and 8
Changes in hand-held dynamometry
Measured: baseline to week 8
Differences (treated vs sham) and change in the slow vital capacity (SVC)
Measured: from baseline to month 6
Differences (treated vs sham) and change in plasma NfL levels
Candidate biomarkers are: SOD1, Ataxin 2, C90rf72, UNC13A, TDP43, stathmin 2, NfL and NfH levels
Measured: baseline to month 6
Change in Motor Evoked Potential (MEP) Amplitudes
ppTMS will be used to assess changes in motor cortex excitability via MEP amplitude (measured in millivolts)
Measured: baseline to week 4 and 8
Change in Resting Motor Threshold
RMT will be recorded to assess baseline motor cortex excitability (measured as a percentage of maximum stimulator output)
Measured: baseline to week 4 and 8
Change in Intra-Cortical Facilitation
ICF will be measured to assess synaptic excitability
Measured: baseline to week 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start24 Oct 2024
- Primary completionApr 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised, double blind, sham controlled clinical study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681610
- Sponsor's protocol ID
- NEU-TPS-ALS-01
- Other IDs
- FUSF-RAP-S-23-00096
- Acronym
- TPS4ALS
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we will provide access to protocol, SAP and ICF
Publications
Voroslakos M, Takeuchi Y, Brinyiczki K, Zombori T, Oliva A, Fernandez-Ruiz A, Kozak G, Kincses ZT, Ivanyi B, Buzsaki G, Berenyi A. Direct effects of transcranial electric stimulation on brain circuits in rats and humans. Nat Commun. 2018 Feb 2;9(1):483. doi: 10.1038/s41467-018-02928-3.
PubMed 29396478Kim HC, Lee W, Kunes J, Yoon K, Lee JE, Foley L, Kowsari K, Yoo SS. Transcranial focused ultrasound modulates cortical and thalamic motor activity in awake sheep. Sci Rep. 2021 Sep 29;11(1):19274. doi: 10.1038/s41598-021-98920-x.
PubMed 34588588Feldman EL, Goutman SA, Petri S, Mazzini L, Savelieff MG, Shaw PJ, Sobue G. Amyotrophic lateral sclerosis. Lancet. 2022 Oct 15;400(10360):1363-1380. doi: 10.1016/S0140-6736(22)01272-7. Epub 2022 Sep 15.
PubMed 36116464
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of the Motor Pathway by Transcranial Pulse Stimulation in People With ALS: a Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT06681610
- Acronym / sponsor ID
- TPS4ALS / NEU-TPS-ALS-01
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- Transcranial Pulse Stimulation (TPS), Amyotrophic Lateral Sclerosis (ALS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Nov 2024 (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 clinical trial is to assess the efficacy of TPS of the motor cortex on biomarkers and clinical endpoints in patients with ALS. The main questions it aims to answer are:
- Stage 1: Is there a change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8?
- Stage 2: Is there a change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score?
In stage 2, researchers will compare the group receiving the stimulation vs the group receiving a sham stimulation to see if there is a difference in motor cortex activity and in the ALSFRS-R score
Participants will receive either:
- the TPS treatment
- a sham TPS treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomised, double blind, sham controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| TPS | Experimental | Device: Transcranial Pulse StimulationThe stimulation will be 20 min duration as indicated in the CE mark approval. Each session involves 6,000 pulses in the hand region of the motor cortex with 3,000 on each side of the brain. The system uses a low energy flux density maximum of 0.25 mJ/mm2 accordingly with EMA and FDA guidelines (high energy is defined as > 0.5 mJ/mm2). The standard therapy involves 6 sessions in 2 weeks as indicated in the CE mark. |
| sham | Sham comparator | Device: Transcranial Pulse StimulationThe transcranial pulse stimulation with the same device and the same protocol uses a membrane on the device that blocks the sound waves. Participants' motor cortex is not stimulated. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with diagnosis of sporadic ALS (definite or clinically probable) as defined by the World Federation of Neurology revised El Escorial criteria
- SVC of 50% or greater of estimated measure and presence of measurable motor evoked potential
- 21 to 80 years old and male or female
Key exclusion criteria (1 listed)
- patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below
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 |
|---|---|---|
| Transcranial Pulse Stimulationlow intensity shock-waves stimulation of the motor cortex, bilateral | Device | TPS, sham |
Primary outcome
Change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8.
Time frame: baseline to week 8
Change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score
Time frame: baseline to week 24
The ALS Functional Rating Scale-Revised Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Higher scores mean a better outcome.
8 secondary outcomes
Change plasma neurofilament light chain (NfL) levels
Time frame: baseline to week 4 and 8
Changes in muscle strength, assessed by the Medical Research Council (MRC) sum score
Time frame: baseline to week 4 and 8
Changes in hand-held dynamometry
Time frame: baseline to week 8
Differences (treated vs sham) and change in the slow vital capacity (SVC)
Time frame: from baseline to month 6
Differences (treated vs sham) and change in plasma NfL levels
Time frame: baseline to month 6
Change in Motor Evoked Potential (MEP) Amplitudes
Time frame: baseline to week 4 and 8
Change in Resting Motor Threshold
Time frame: baseline to week 4 and 8
Change in Intra-Cortical Facilitation
Time frame: baseline to week 4 and 8
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 8 Nov 2024.
- Background: PubMed 29396478Voroslakos M, Takeuchi Y, Brinyiczki K, Zombori T, Oliva A, Fernandez-Ruiz A, Kozak G, Kincses ZT, Ivanyi B, Buzsaki G, Berenyi A. Direct effects of transcranial electric stimulation on brain circuits in rats and humans. Nat Commun. 2018 Feb 2;9(1):483. doi: 10.1038/s41467-018-02928-3.
- Background: PubMed 34588588Kim HC, Lee W, Kunes J, Yoon K, Lee JE, Foley L, Kowsari K, Yoo SS. Transcranial focused ultrasound modulates cortical and thalamic motor activity in awake sheep. Sci Rep. 2021 Sep 29;11(1):19274. doi: 10.1038/s41598-021-98920-x.
- Background: PubMed 36116464Feldman EL, Goutman SA, Petri S, Mazzini L, Savelieff MG, Shaw PJ, Sobue G. Amyotrophic lateral sclerosis. Lancet. 2022 Oct 15;400(10360):1363-1380. doi: 10.1016/S0140-6736(22)01272-7. Epub 2022 Sep 15.
- Individual participant dataSharing planned: Yes. we will provide access to protocol, SAP and ICF
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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 Transcranial Pulse Stimulation in people with Amyotrophic Lateral Sclerosis (ALS), run by Parc de Salut Mar at 1 site in Spain.
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 3 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: looking for participants now, as of the sponsor's last update on 8 Nov 2024. 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 Spain. 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?
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?
Contact Alba Leon, MD (+34932 48 30 00, aleonjorba@psmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8. (time frame: baseline to week 8). The study lists 2 primary outcomes in all. 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 NCT06681610, which also lists 3 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 8 Nov 2024; AzTrials last refreshed its copy on 4 Nov 2026.