Primary Progressive AphasiaNCT04431401
rTMS Treatment of Primary Progressive Aphasia
A study testing Magstim rTMS in people with Primary Progressive Aphasia and Repetitive Transcranical Magnetic Stimulation, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Primary Progressive Aphasia (PPA) is a neurodegenerative disease in which language function is gradually and progressively impaired. Patients will eventually be disabled in communication and have cognition deficits, which put a heavy burden not only on their families but also on the whole society. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Progressive Aphasia, Repetitive Transcranical Magnetic Stimulation
- What is being tested?
- Magstim rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 31 Aug 2022
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of PPA
Who cannot join
- Scored below 15 on the mini-mental state exam (MMSE)
- history of seizures or unexplained loss of consciousness
- pregnancy
- surgical breach of the skull
- MRI contraindication
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Repetitive Transcranial Magnetic Stimulation in the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial
Primary Progressive Aphasia (PPA) is a neurodegenerative disease in which language function is gradually and progressively impaired. Patients will eventually be disabled in communication and have cognition deficits, which put a heavy burden not only on their families but also on the whole society. However, no effective treatment for PPA has been explored so far. The current clinical randomized trial is to study the safety and efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) for the treatment of PPA. Also, multi-modality of neuroimaging techniques, such as functional MRI and PET will be used to investigate brain network changing in this procedure.
- Being tested
- Magstim rTMS
- 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.
Magstim rTMSDevice
The device is made in London,UK
| Study group | Role | What they receive |
|---|---|---|
| rTMS treatment group | Experimental | The participants will be divided into the rTMS treatment group and the sham treatment group by means of randomized methods.The protocol of the treatment is to use rTMS with high frequency 10/20Hz 120%RMT 20 times for one month. The device is Magtism rTMS made in London, UK Receives: Device: Magstim rTMS |
| sham treatment group | Sham comparator | The control group is to receive sham treatment. The device is the same as the one used in the real treatment group. Receives: Device: Magstim rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston naming test evaluation
Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.
Measured: 1 day before the treatment
Boston naming test evaluation
Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.
Measured: 1 month, 3 months and 6 months after the treatment
Western Aphasia Battery (WAB) Speech fluency
Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.
Measured: 1 day before the treatment
Western Aphasia Battery (WAB) Speech fluency
Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.
Measured: 1 month, 3 months and 6 months after the treatment
Western Aphasia Battery (WAB) Repetition
Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.
Measured: 1 day before the treatment
Western Aphasia Battery (WAB) Repetition
Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.
Measured: 1 month, 3 months and 6 months after the treatment
Western Aphasia Battery (WAB) Word recognition
Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.
Measured: 1 day before the treatment
Western Aphasia Battery (WAB) Word recognition
Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.
Measured: 1 month, 3 months and 6 months after the treatment
Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)
Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.
Measured: 1 day before the treatment
Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)
Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.
Measured: 1 month, 3 months and 6 months after the treatment
Secondary outcomes (4)
functional connectivity map (FC map)
Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The language related brain areas, such as Broca Area and Wernicke Area, were defined as the regions of interest (ROI). Pearson's correlation analysis between the time course of the ROI and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps. This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement.
Measured: 1 day before the treatment
functional connectivity map (FC map)
Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The language related brain areas, such as Broca Area and Wernicke Area, were defined as the regions of interest (ROI). Pearson's correlation analysis between the time course of the ROI and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps. This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement.
Measured: 1 month, 3 months and 6 months after the treatment
Standardized Uptake Value (SUV)
PET parameter to evaluate brain metabolism
Measured: 1 day before the treatment
Standardized Uptake Value (SUV)
PET parameter to evaluate brain metabolism
Measured: 1 month, 3 months and 6 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2022
- Study completion31 Aug 2022
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.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431401
- Sponsor's protocol ID
- PPA-rTMS
- Status last verified
- Mar 2023
- First submitted
- 3 Jun 2020
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang Y, Tan Y, Hao H, Li J, Liu C, Hu Y, Wu Y, Ding Q, Zhou Y, Li Y, Guan Y. Treatment of primary progressive aphasia by repetitive transcranial magnetic stimulation: a randomized, double-blind, placebo-controlled study. J Neural Transm (Vienna). 2023 Feb;130(2):111-123. doi: 10.1007/s00702-023-02594-w. Epub 2023 Jan 20.
PubMed 36662282
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation in the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04431401
- Acronym / sponsor ID
- PPA-rTMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 16 Jun 2020 (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 neurodegenerative disease in which language function is gradually and progressively impaired. Patients will eventually be disabled in communication and have cognition deficits, which put a heavy burden not only on their families but also on the whole society. However, no effective treatment for PPA has been explored so far. The current clinical randomized trial is to study the safety and efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) for the treatment of PPA. Also, multi-modality of neuroimaging techniques, such as functional MRI and PET will be used to investigate brain network changing in this procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS treatment group | Experimental | Device: Magstim rTMSThe participants will be divided into the rTMS treatment group and the sham treatment group by means of randomized methods.The protocol of the treatment is to use rTMS with high frequency 10/20Hz 120%RMT 20 times for one month. The device is Magtism rTMS made in London, UK |
| sham treatment group | Sham comparator | Device: Magstim rTMSThe control group is to receive sham treatment. The device is the same as the one used in the real treatment group. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of PPA
Key exclusion criteria (5 listed)
- Scored below 15 on the mini-mental state exam (MMSE)
- history of seizures or unexplained loss of consciousness
- pregnancy
- surgical breach of the skull
- MRI contraindication
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 |
|---|---|---|
| Magstim rTMSThe device is made in London,UK | Device | rTMS treatment group, sham treatment group |
Primary outcome
Boston naming test evaluation
Time frame: 1 day before the treatment
Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.
Boston naming test evaluation
Time frame: 1 month, 3 months and 6 months after the treatment
Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.
Western Aphasia Battery (WAB) Speech fluency
Time frame: 1 day before the treatment
Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.
Western Aphasia Battery (WAB) Speech fluency
Time frame: 1 month, 3 months and 6 months after the treatment
Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.
Western Aphasia Battery (WAB) Repetition
Time frame: 1 day before the treatment
Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.
Western Aphasia Battery (WAB) Repetition
Time frame: 1 month, 3 months and 6 months after the treatment
Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.
Western Aphasia Battery (WAB) Word recognition
Time frame: 1 day before the treatment
Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.
Western Aphasia Battery (WAB) Word recognition
Time frame: 1 month, 3 months and 6 months after the treatment
Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.
Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)
Time frame: 1 day before the treatment
Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.
Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)
Time frame: 1 month, 3 months and 6 months after the treatment
Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.
4 secondary outcomes
functional connectivity map (FC map)
Time frame: 1 day before the treatment
functional connectivity map (FC map)
Time frame: 1 month, 3 months and 6 months after the treatment
Standardized Uptake Value (SUV)
Time frame: 1 day before the treatment
Standardized Uptake Value (SUV)
Time frame: 1 month, 3 months and 6 months after the treatment
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 12 Jan 2024.
- Derived from this study: PubMed 36662282Huang Y, Tan Y, Hao H, Li J, Liu C, Hu Y, Wu Y, Ding Q, Zhou Y, Li Y, Guan Y. Treatment of primary progressive aphasia by repetitive transcranial magnetic stimulation: a randomized, double-blind, placebo-controlled study. J Neural Transm (Vienna). 2023 Feb;130(2):111-123. doi: 10.1007/s00702-023-02594-w. Epub 2023 Jan 20.
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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 Magstim rTMS in people with Primary Progressive Aphasia and Repetitive Transcranical Magnetic Stimulation, run by Peking Union Medical College Hospital at 1 site in China.
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 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 12 Jan 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 China. 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?
Boston naming test evaluation (time frame: 1 day before the treatment). The study lists 10 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 NCT04431401, 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 12 Jan 2024.