Aphasia, Primary ProgressiveNCT03448133
rTMS for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial
A study testing Magstim rTMS in people with Aphasia, Primary Progressive and Repetitive Transcranical Magnetic Stimulation, run by Peking Union Medical College Hospital.
Trial summary
The primary progressive aphasia (PPA) is a neurodegenerative condition characterized by a gradual, irreversible decline of language function (Mesulam, 2001). There are no known treatments for PPA so far. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphasia, Primary Progressive, 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 31 Dec 2021
- 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
- All participants had also been evaluated previously by a behavioral neurologist at the Peking Union Medical College Hospital and had been clinically diagnosed with a variant of PPA.
Who cannot join
- Scored below 15 on the mini-mental state exam (MMSE) due to concerns that global cognitive impairment might preclude their ability to follow the directions and interfere with task performance.
- Had a history of seizures or unexplained loss of consciousness, pregnancy, surgical breach of the skull, or any other medical or surgical contraindication to receiving noninvasive brain stimulation.
- Is unable to complete the treatment and evaluations
About this study
Official title: Repetitive Transcranial Magnetic Stimulation for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Tria
The primary progressive aphasia (PPA) is a neurodegenerative condition characterized by a gradual, irreversible decline of language function (Mesulam, 2001). There are no known treatments for PPA so far. The relentless progression of PPA symptoms eventually leads to a profound impairment in communication ability and, ultimately, to more generalized deficits of cognition. Some cases and small studies reported that Transcranial Magnetic Stimulation (TMS), one of the non-invasive neuromodulation tech, can be employed to facilitate language production and improve the language ability in patients with PPA. Herein we will explore the tolerance and efficacy of TMS for the treatment of PPA by the randomized controlled trial .Meanwhile the functional MRI tech will be used to investigate the neural network changing in the 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 devided into rTMS treatment and sham treatment by means of randomized methods.The protocol of 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
Measured: Baseline
Boston naming test evaluation
Assessment of the language production
Measured: One month(just after 20 times rTMS treatment)
Western Aphasia Battery(WAB) Speech fluency
Assessment of the language production
Measured: Baseline
Western Aphasia Battery(WAB) Speech fluency
Assessment of the language production
Measured: One month(just after 20 times rTMS treatment)
Repetition Part of WAB
Assessment of the repetition ability
Measured: Baseline
Repetition Part of WAB
Assessment of the repetition ability
Measured: One month(just after 20 times rTMS treatment)
Word recognition Part of WAB
Assessment of the reading
Measured: Baseline
Word recognition Part of WAB
Assessment of the reading
Measured: One month(just after 20 times rTMS treatment)
Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)
Assessment of the grammar ability
Measured: Baseline
Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)
Assessment of the grammar ability
Measured: One month(just after 20 times rTMS treatment)
Secondary outcomes (2)
fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)
Graph theoretical analysis of the speech/language network
Measured: Baseline
fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)
Graph theoretical analysis of the speech/language network
Measured: One month(just after 20 times rTMS treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Mar 2018 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: Because of the expiration of the previous ethical approval documents
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia, Primary ProgressiveStudies 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
- 0 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
- NCT03448133
- Sponsor's protocol ID
- rTMSPPA-PUMCH
- Status last verified
- Jun 2020
- First submitted
- 10 Feb 2018
- Last updated
- 5 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Tria
- ClinicalTrials.gov ID
- NCT03448133
- Acronym / sponsor ID
- rTMSPPA-PUMCH
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of the expiration of the previous ethical approval documents
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Feb 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.
The primary progressive aphasia (PPA) is a neurodegenerative condition characterized by a gradual, irreversible decline of language function (Mesulam, 2001). There are no known treatments for PPA so far. The relentless progression of PPA symptoms eventually leads to a profound impairment in communication ability and, ultimately, to more generalized deficits of cognition. Some cases and small studies reported that Transcranial Magnetic Stimulation (TMS), one of the non-invasive neuromodulation tech, can be employed to facilitate language production and improve the language ability in patients with PPA. Herein we will explore the tolerance and efficacy of TMS for the treatment of PPA by the randomized controlled trial .Meanwhile the functional MRI tech will be used to investigate the neural network changing in the 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 devided into rTMS treatment and sham treatment by means of randomized methods.The protocol of 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)
- All participants had also been evaluated previously by a behavioral neurologist at the Peking Union Medical College Hospital and had been clinically diagnosed with a variant of PPA.
Key exclusion criteria (3 listed)
- Scored below 15 on the mini-mental state exam (MMSE) due to concerns that global cognitive impairment might preclude their ability to follow the directions and interfere with task performance.
- Had a history of seizures or unexplained loss of consciousness, pregnancy, surgical breach of the skull, or any other medical or surgical contraindication to receiving noninvasive brain stimulation.
- Is unable to complete the treatment and evaluations
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: Baseline
Assessment of the language production
Boston naming test evaluation
Time frame: One month(just after 20 times rTMS treatment)
Assessment of the language production
Western Aphasia Battery(WAB) Speech fluency
Time frame: Baseline
Assessment of the language production
Western Aphasia Battery(WAB) Speech fluency
Time frame: One month(just after 20 times rTMS treatment)
Assessment of the language production
Repetition Part of WAB
Time frame: Baseline
Assessment of the repetition ability
Repetition Part of WAB
Time frame: One month(just after 20 times rTMS treatment)
Assessment of the repetition ability
Word recognition Part of WAB
Time frame: Baseline
Assessment of the reading
Word recognition Part of WAB
Time frame: One month(just after 20 times rTMS treatment)
Assessment of the reading
Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)
Time frame: Baseline
Assessment of the grammar ability
Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)
Time frame: One month(just after 20 times rTMS treatment)
Assessment of the grammar ability
2 secondary outcomes
fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)
Time frame: Baseline
fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)
Time frame: One month(just after 20 times rTMS treatment)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Magstim rTMS in people with Aphasia, Primary Progressive and Repetitive Transcranical Magnetic Stimulation, run by Peking Union Medical College Hospital.
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 3 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: withdrawn, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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: Baseline). 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?
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 5 Jun 2020.