Primary Progressive AphasiaNCT03580954
Transcranial Magnetic Stimulation in Primary Progressive Aphasia
A study testing Transcranial Magnetic Stimulation in people with Primary Progressive Aphasia, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Primary progressive aphasia (PPA) is a clinical syndrome characterized by the neurodegeneration of language brain systems. Three main clinical variants are currently recorgnized (nonfluent, semantic, and logopenic PPA). Nowadays, there are no effective treatments for this disorder. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Primary Progressive Aphasia
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2018to 10 Mar 2020
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be clinically diagnosed of PPA according to current diagnostic criteria (Gorno-Tempini et al. 2011) with PET-FDG confirmation.
- Clinical Dementia Rating 0-1.
Who cannot join
- Contraindications for TMS or MRI
- History of epilepsy
- Pregnancy
- Other language disorder previous to the diagnosis of PPA
- Neuroimaging not suggestive of PPA
Trial locations and contacts
1 site in 1 country.
About this study
Primary progressive aphasia (PPA) is a clinical syndrome characterized by the neurodegeneration of language brain systems. Three main clinical variants are currently recorgnized (nonfluent, semantic, and logopenic PPA). Nowadays, there are no effective treatments for this disorder.
Transcranial Magnetic Stimulation (TMS) is a technique based on the principle of electromagnetic induction of an electric field in the brain. It has been used as a non-invasive therapy in different disorders, such as depression, bipolar disorder, Parkinson's disease, and in the rehabilitation of post-stroke aphasia. Recent studies have shown how repetitive TMS improved language characteristics in Alzheimer's disease, and there are initial data in patients with PPA.
This research project investigates the effect of repetitive TMS in patients with PPA. Investigators will perform a personalized TMS treatment for each patient (brain region, type of stimulation/inhibition, etc.), according to the specific characteristics of each patient and with the final aim to generate a computational model.
- Conditions
- Primary Progressive Aphasia
- Being tested
- Transcranial Magnetic Stimulation
- Medical subject headings
- Aphasia, Primary Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Stimulation or inhibition using TMS will be delivered guided by a neuronavigator system in different brain regions.
| Study group | Role | What they receive |
|---|---|---|
| Repetitive TMS (estimulation) | Experimental | Not described Receives: Device: Transcranial Magnetic Stimulation |
| Repetitive TMS (inhibition) | Active comparator | Not described Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in spontaneous speech (main primary endpoint)
Picture and story description task
Measured: 2 months (at baseline and at the end of the treatment)
Changes in oral naming
Object naming test
Measured: 2 months
Changes in reading
Story and words reading test
Measured: 2 months
Changes in repetition
Non-words and sentence repetition task
Measured: 2 months (at baseline and at the end of the treatment)
Secondary outcomes (5)
Changes in brain metabolism
Brain metabolism measured using 18F-FDG-PET
Measured: 2 months (at baseline and at the end of the treatment)
Changes in clinical impression of change
Patient's clinical impression of change (from 0 to 10)
Measured: 2 months (at baseline and at the end of the treatment)
Changes in brain cortical electrical activity
Changes in the brain cortical electrical activity measured using quantitative electroencephalography (EEG)
Measured: 2 months (at baseline and at the end of the treatment)
Changes in global cognition
Addenbrooke's Cognitive Examination III
Measured: 2 months (at baseline and at the end of the study)
Changes in clinical impression of change
Caregiver's clinical impression of change (from 0 to 10)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start1 Feb 2018
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Progressive AphasiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Responsible party
- Principal investigator, Jordi A Matias-Guiu, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580954
- Sponsor's protocol ID
- 17/247-E
- Status last verified
- May 2020
- First submitted
- 17 Apr 2018
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pytel V, Cabrera-Martin MN, Delgado-Alvarez A, Ayala JL, Balugo P, Delgado-Alonso C, Yus M, Carreras MT, Carreras JL, Matias-Guiu J, Matias-Guiu JA. Personalized Repetitive Transcranial Magnetic Stimulation for Primary Progressive Aphasia. J Alzheimers Dis. 2021;84(1):151-167. doi: 10.3233/JAD-210566.
PubMed 34487043
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation in Primary Progressive Aphasia
- ClinicalTrials.gov ID
- NCT03580954
- Acronym / sponsor ID
- 17/247-E
- Conditions
- Primary Progressive Aphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 10 Jul 2018 (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.
Primary progressive aphasia (PPA) is a clinical syndrome characterized by the neurodegeneration of language brain systems. Three main clinical variants are currently recorgnized (nonfluent, semantic, and logopenic PPA). Nowadays, there are no effective treatments for this disorder.
Transcranial Magnetic Stimulation (TMS) is a technique based on the principle of electromagnetic induction of an electric field in the brain. It has been used as a non-invasive therapy in different disorders, such as depression, bipolar disorder, Parkinson's disease, and in the rehabilitation of post-stroke aphasia. Recent studies have shown how repetitive TMS improved language characteristics in Alzheimer's disease, and there are initial data in patients with PPA.
This research project investigates the effect of repetitive TMS in patients with PPA. Investigators will perform a personalized TMS treatment for each patient (brain region, type of stimulation/inhibition, etc.), according to the specific characteristics of each patient and with the final aim to generate a computational model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repetitive TMS (estimulation) | Experimental | Device: Transcranial Magnetic Stimulation |
| Repetitive TMS (inhibition) | Active comparator | Device: Transcranial Magnetic Stimulation |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be clinically diagnosed of PPA according to current diagnostic criteria (Gorno-Tempini et al. 2011) with PET-FDG confirmation.
- Clinical Dementia Rating 0-1.
Key exclusion criteria (5 listed)
- Contraindications for TMS or MRI
- History of epilepsy
- Pregnancy
- Other language disorder previous to the diagnosis of PPA
- Neuroimaging not suggestive of PPA
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 Magnetic StimulationStimulation or inhibition using TMS will be delivered guided by a neuronavigator system in different brain regions. | Device | Repetitive TMS (estimulation), Repetitive TMS (inhibition) |
Primary outcome
Changes in spontaneous speech (main primary endpoint)
Time frame: 2 months (at baseline and at the end of the treatment)
Picture and story description task
Changes in oral naming
Time frame: 2 months
Object naming test
Changes in reading
Time frame: 2 months
Story and words reading test
Changes in repetition
Time frame: 2 months (at baseline and at the end of the treatment)
Non-words and sentence repetition task
5 secondary outcomes
Changes in brain metabolism
Time frame: 2 months (at baseline and at the end of the treatment)
Changes in clinical impression of change
Time frame: 2 months (at baseline and at the end of the treatment)
Changes in brain cortical electrical activity
Time frame: 2 months (at baseline and at the end of the treatment)
Changes in global cognition
Time frame: 2 months (at baseline and at the end of the study)
Changes in clinical impression of change
Time frame: 2 months
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 14 May 2020.
- Derived from this study: PubMed 34487043Pytel V, Cabrera-Martin MN, Delgado-Alvarez A, Ayala JL, Balugo P, Delgado-Alonso C, Yus M, Carreras MT, Carreras JL, Matias-Guiu J, Matias-Guiu JA. Personalized Repetitive Transcranial Magnetic Stimulation for Primary Progressive Aphasia. J Alzheimers Dis. 2021;84(1):151-167. doi: 10.3233/JAD-210566.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Magnetic Stimulation in people with Primary Progressive Aphasia, run by Hospital San Carlos, Madrid 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 2 inclusion and 5 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 14 May 2020. 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. 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?
Changes in spontaneous speech (main primary endpoint) (time frame: 2 months (at baseline and at the end of the treatment)). The study lists 4 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 NCT03580954, which also lists 1 linked publication.
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 14 May 2020.