Alzheimer DiseaseNCT04045990
Network Modulation in Alzheimer's Disease
A study testing repetitive transcranial magnetic stimulation (rTMS) in people with Alzheimer Disease and Primary Progressive Aphasia, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of non-invasive brain stimulation on memory and language ability in patients with two phenotypic variations of underlying Alzheimer disease pathology: amnestic mild cognitive impairment (aMCI) and logopenic variant of primary progressive aphasia (lvPPA). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Alzheimer Disease, Primary Progressive Aphasia, Mild Cognitive Impairment
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 1 Mar 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, age 18-90, who carry a diagnosis of either the logopenic variant (lvPPA) of PPA or amnestic MCI (aMCI). Patients must have been observed for at least one year by a specialized clinician.
- The presence of underlying AD pathology must be verified by a prior amyloid-PET and/or Tau-PET imaging (done as part of a prior protocol), or CSF biomarkers of AD pathology.
- Patients with lvPPA must have at least mild to moderate language impairment.
- Patients with aMCI must meet criteria for this condition, including the presence of at least mild to moderate episodic memory impairment.
- Patients must be native English speakers.
- Patients must have a study partner (e.g. spouse, sibling, adult child, friend) who can accompany them to all study visits.
Who cannot join
- Any history of seizures, unexplained loss of consciousness or a first-degree family member with epilepsy (to ensure safety to receive rTMS).
- Any history of significant co-occurring neurological illness unrelated to the neurodegenerative disease in question (e.g. multiple sclerosis), or significant medical problems (e.g. poorly controlled diabetes/hypertension or cancer within 5 years).
- Active symptoms of major depressive disorder, bipolar disorder, schizophrenia, substance use disorder or significant premorbid intellectual disability according to DSM criteria.
- MRI evidence of significant (e.g. confluent leukoariosis or stroke) cerebrovascular disease, hydrocephalus or the presence of a space-occupying intra-cranial mass.
- Contraindications to MRI or rTMS including: cardiac pacemaker or pacemaker wires, neurostimulators, implanted pumps, metal in the body (rods, plates, screws, shrapnel, dentures, IUD), surgical aneurysm clips in the head, previous neurosurgery or cochlear implants.
- In line with published MGH IRB guidelines for rTMS, pregnancy must be ruled out by urine ß-HCG if answers to screening questions suggest that pregnancy is possible and if female participants are premenopausal and of child-bearing age. Subjects will not be able to enroll if they are breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
About this study
Official title: Neuromodulation of Language and Memory Networks in Alzheimer's Disease
The purpose of this study is to assess the effects of non-invasive brain stimulation on memory and language ability in patients with two phenotypic variations of underlying Alzheimer disease pathology: amnestic mild cognitive impairment (aMCI) and logopenic variant of primary progressive aphasia (lvPPA). This study will use repetitive Transcranial Magnetic Stimulation (rTMS) to stimulate nodes of networks that are thought to be affected in these two conditions. Specifically, a node of the Default Mode Network (DMN)-the angular gyrus (AG)-will be stimulated in aMCI patients; and a node of the language network-the posterior inferior frontal gyrus (pIFG) will be stimulated in patients with lvPPA.
We will use functional connectivity MRI (fcMRI) to assess changes in functional network architecture following the stimulation. We will also assess putative cognitive improvements resulting from the stimulation by in-depth language testing in lvPPA patients and in-depth memory testing in aMCI patients.
Read the detailed description
Specific Aims
Aim 1: To investigate the feasibility of selective rTMS modulation of the Default Mode Network (DMN) vs. language network in patients with aMCI and lvPPA. We will assess the reliability of the rTMS/fcMRI approach to network modulation by studying the same subjects over repeated sessions, with the same methodology, including appropriate sham stimulation conditions.
Hypothesis 1a: Changes in network functional connectivity following excitatory rTMS to AG (a node of the DMN) and pIFG (a node of the language network) across identical stimulation sessions separated in time, will show minimal within subject variability in aMCI and lvPPA patients, respectively, thus confirming the reliability of the approach and the reproducibility of prior findings demonstrating connectivity changes within the DMN and language networks.
Hypothesis 1b: High frequency rTMS to pIFG will reliably increase pIFG-SMG-pMTG functional connectivity within the language network; high frequency rTMS to AG will reliably increase functional connectivity between pIPL and HF in the DMN.
Hypothesis 1c: The changes in network functional connectivity will be selective, in that stimulation to AG (in the DMN) will not modulate connectivity within the language network, while stimulation to pIFG (in the language network) will not modulate DMN connectivity.
Aim 2: To assess the effects of rTMS modulation on memory and language function in patients with aMCI and lvPPA.
Hypothesis 2a: Excitatory rTMS to the language network will be associated with improved language performance in patients with lvPPA.
Hypothesis 2b: Excitatory rTMS to the DMN will be associated with improved memory performance in patients with aMCI.
Hypothesis 2c: Cognitive improvements will persist for at least two weeks following cessation of rTMS.
Aim 3: To identify the functional network mechanisms underlying cognitive improvement in patients with aMCI and lvPPA after rTMS.
Hypothesis 3a: Alterations in intrinsic functional connectivity (as assessed with fcMRI) within each network following rTMS will correlate with improved cognitive performance.
Hypothesis 3b: Patients with a greater degree of atrophy and tau pathology within each network (assessed in a prior study) at baseline will predict a lesser response to rTMS.
We will recruit up to 20 patients with aMCI and up to 20 patients with lvPPA (with amyloid and tau imaging or CSF biomarkers supportive of underlying AD pathology). We will first perform a baseline functional connectivity MRI (fcMRI), the purpose of which will be to obtain individualized network maps which can be used to target the networks of interest during future sessions.
This will be followed by up to two weeks of five consecutive days of stimulation (Monday through Friday). aMCI patients will receive stimulation to the angular gyrus (AG) node of the DMN, and lvPPA patients will receive stimulation to the posterior inferior frontal gyrus (pIFG) node of the language network. During one of the two weeks stimulation will be active, and during the other week stimulation will be SHAM. Order of active and SHAM stimulation blocks will be counterbalanced.
We will concomitantly assess the effects of rTMS modulation on memory and language function in patients with aMCI and lvPPA, and in so doing identify the functional network mechanisms underlying cognitive improvement after rTMS. Language and memory assessments will be performed on days 1 (Monday) , 3 (Wednesday) and 5 (Friday) of the week. Finally, to assess the distributed effects of the stimulation upon functional connectivity, fcMRI will be performed on days 1 (Monday) and 5 (Friday).
We anticipate these results will lead to an impactful manuscript showing proof-of-concept data: 1) that it is possible to improve memory in aMCI and language in lvPPA using rTMS targeted selectively to the relevant brain network, and: 2) regarding mechanisms underlying the effects of rTMS on network function.
- Being tested
- repetitive transcranial magnetic stimulation (rTMS)
- Medical subject headings
- Alzheimer Disease, Aphasia, Primary Progressive, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (rTMS)Device
rTMS is a method to focally and reversibly stimulate a pre-specified cortical target. rTMS works through the principle of electromagnetic induction.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | Active rTMS will be administered with a MagPro X100 stimulator (MagVenture, Denmark), using a 70 mm figure-of-eight liquid cooled coil capable of doing active or sham stimulation (e.g. the Cool B70 coil or the Cool B65 A/P coil). Active rTMS will be delivered at 80-120% of a patient's resting or active motor threshold. rTMS will be administered in an excitatory pattern as 20Hz. Stimulation parameters will remain well within established safety guidelines (Rossi et al. 2009). Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
| SHAM stimulation | Sham comparator | SHAM stimulation will also be administered with a MagPro X100 stimulator (MagVenture, Denmark), using a 70 mm figure-of-eight liquid cooled coil capable of doing active or sham stimulation (e.g. the Cool B70 coil or the Cool B65 A/P coil). SHAM rTMS will be delivered at 80-120% of a patient's resting or active motor threshold. SHAM stimulation will be delivered to the exact same cortical targets as active rTMS. While no electromagnetic stimulation will be delivered during SHAM, the sounds will approximate active stimulation and skin electrodes will approximate the sensation of active rTMS. Inclusion of a sham condition in this protocol is critical to measure whether or not the stimulation is improving memory or language performance, or whether practice effects or other non-specific effects are responsible for any changes in memory or language performance which may be observed. Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Naming Test
A test of confrontation naming of drawn pictures.
Measured: Up to 5 weeks
Western Aphasia Battery-repetition
A test of the ability to repeat phonetically complex phrases
Measured: Up to 5 weeks
Western Aphasia Battery-reading comprehension
A test of the ability to correctly comprehend read material
Measured: Up to 5 weeks
Western Aphasia Battery-spelling
A test of the ability to spell irregular words.
Measured: Up to 5 weeks
Controlled Oral Word Association Test
A test of word generation, e.g. generation of as many words as possible beginning with a certain letter of the alphabet.
Measured: Up to 5 weeks
Cambridge Semantic Battery
A test of semantic knowledge through word-pairings.
Measured: Up to 5 weeks
The Northwestern Anagram Test
A test of non-verbal production of sentences.
Measured: Up to 5 weeks
Picture Description Test
A test in which patients write a paragraph describing a picture, such as a picnic or the cookie theft picture.
Measured: Up to 5 weeks
Changes in intrinsic functional connectivity
Changes in region-to-region functional connectivity within the stimulated networks will be assessed, e.g. changes in connectivity in the DMN will be assessed in aMCI patients and changes in the language network will be assessed in lvPPA patients.
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Sep 2018
- Primary completion31 Jan 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Not applicable
- Intervention model
- Crossover
- Model description
- Patients with each condition will each undergo, in a crossover, within-subject design, two clocks of rTMS: active and SHAM.The order of active and SHAM blocks will be counterbalanced across subjects.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Eldaief, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045990
- Sponsor's protocol ID
- 2018P001362
- Status last verified
- Mar 2022
- First submitted
- 29 Aug 2018
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share IPD with researchers outside of this protocol.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation of Language and Memory Networks in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04045990
- Acronym / sponsor ID
- 2018P001362
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 6 Aug 2019 (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 purpose of this study is to assess the effects of non-invasive brain stimulation on memory and language ability in patients with two phenotypic variations of underlying Alzheimer disease pathology: amnestic mild cognitive impairment (aMCI) and logopenic variant of primary progressive aphasia (lvPPA). This study will use repetitive Transcranial Magnetic Stimulation (rTMS) to stimulate nodes of networks that are thought to be affected in these two conditions. Specifically, a node of the Default Mode Network (DMN)-the angular gyrus (AG)-will be stimulated in aMCI patients; and a node of the language network-the posterior inferior frontal gyrus (pIFG) will be stimulated in patients with lvPPA.
We will use functional connectivity MRI (fcMRI) to assess changes in functional network architecture following the stimulation. We will also assess putative cognitive improvements resulting from the stimulation by in-depth language testing in lvPPA patients and in-depth memory testing in aMCI patients.
Detailed description
Specific Aims
Aim 1: To investigate the feasibility of selective rTMS modulation of the Default Mode Network (DMN) vs. language network in patients with aMCI and lvPPA. We will assess the reliability of the rTMS/fcMRI approach to network modulation by studying the same subjects over repeated sessions, with the same methodology, including appropriate sham stimulation conditions.
Hypothesis 1a: Changes in network functional connectivity following excitatory rTMS to AG (a node of the DMN) and pIFG (a node of the language network) across identical stimulation sessions separated in time, will show minimal within subject variability in aMCI and lvPPA patients, respectively, thus confirming the reliability of the approach and the reproducibility of prior findings demonstrating connectivity changes within the DMN and language networks.
Hypothesis 1b: High frequency rTMS to pIFG will reliably increase pIFG-SMG-pMTG functional connectivity within the language network; high frequency rTMS to AG will reliably increase functional connectivity between pIPL and HF in the DMN.
Hypothesis 1c: The changes in network functional connectivity will be selective, in that stimulation to AG (in the DMN) will not modulate connectivity within the language network, while stimulation to pIFG (in the language network) will not modulate DMN connectivity.
Aim 2: To assess the effects of rTMS modulation on memory and language function in patients with aMCI and lvPPA.
Hypothesis 2a: Excitatory rTMS to the language network will be associated with improved language performance in patients with lvPPA.
Hypothesis 2b: Excitatory rTMS to the DMN will be associated with improved memory performance in patients with aMCI.
Hypothesis 2c: Cognitive improvements will persist for at least two weeks following cessation of rTMS.
Aim 3: To identify the functional network mechanisms underlying cognitive improvement in patients with aMCI and lvPPA after rTMS.
Hypothesis 3a: Alterations in intrinsic functional connectivity (as assessed with fcMRI) within each network following rTMS will correlate with improved cognitive performance.
Hypothesis 3b: Patients with a greater degree of atrophy and tau pathology within each network (assessed in a prior study) at baseline will predict a lesser response to rTMS.
We will recruit up to 20 patients with aMCI and up to 20 patients with lvPPA (with amyloid and tau imaging or CSF biomarkers supportive of underlying AD pathology). We will first perform a baseline functional connectivity MRI (fcMRI), the purpose of which will be to obtain individualized network maps which can be used to target the networks of interest during future sessions.
This will be followed by up to two weeks of five consecutive days of stimulation (Monday through Friday). aMCI patients will receive stimulation to the angular gyrus (AG) node of the DMN, and lvPPA patients will receive stimulation to the posterior inferior frontal gyrus (pIFG) node of the language network. During one of the two weeks stimulation will be active, and during the other week stimulation will be SHAM. Order of active and SHAM stimulation blocks will be counterbalanced.
We will concomitantly assess the effects of rTMS modulation on memory and language function in patients with aMCI and lvPPA, and in so doing identify the functional network mechanisms underlying cognitive improvement after rTMS. Language and memory assessments will be performed on days 1 (Monday) , 3 (Wednesday) and 5 (Friday) of the week. Finally, to assess the distributed effects of the stimulation upon functional connectivity, fcMRI will be performed on days 1 (Monday) and 5 (Friday).
We anticipate these results will lead to an impactful manuscript showing proof-of-concept data: 1) that it is possible to improve memory in aMCI and language in lvPPA using rTMS targeted selectively to the relevant brain network, and: 2) regarding mechanisms underlying the effects of rTMS on network function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients with each condition will each undergo, in a crossover, within-subject design, two clocks of rTMS: active and SHAM.The order of active and SHAM blocks will be counterbalanced across subjects.
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS)Active rTMS will be administered with a MagPro X100 stimulator (MagVenture, Denmark), using a 70 mm figure-of-eight liquid cooled coil capable of doing active or sham stimulation (e.g. the Cool B70 coil or the Cool B65 A/P coil). Active rTMS will be delivered at 80-120% of a patient's resting or active motor threshold. rTMS will be administered in an excitatory pattern as 20Hz. Stimulation parameters will remain well within established safety guidelines (Rossi et al. 2009). |
| SHAM stimulation | Sham comparator | Device: repetitive transcranial magnetic stimulation (rTMS)SHAM stimulation will also be administered with a MagPro X100 stimulator (MagVenture, Denmark), using a 70 mm figure-of-eight liquid cooled coil capable of doing active or sham stimulation (e.g. the Cool B70 coil or the Cool B65 A/P coil). SHAM rTMS will be delivered at 80-120% of a patient's resting or active motor threshold. SHAM stimulation will be delivered to the exact same cortical targets as active rTMS. While no electromagnetic stimulation will be delivered during SHAM, the sounds will approximate active stimulation and skin electrodes will approximate the sensation of active rTMS. Inclusion of a sham condition in this protocol is critical to measure whether or not the stimulation is improving memory or language performance, or whether practice effects or other non-specific effects are responsible for any changes in memory or language performance which may be observed. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients, age 18-90, who carry a diagnosis of either the logopenic variant (lvPPA) of PPA or amnestic MCI (aMCI). Patients must have been observed for at least one year by a specialized clinician.
- The presence of underlying AD pathology must be verified by a prior amyloid-PET and/or Tau-PET imaging (done as part of a prior protocol), or CSF biomarkers of AD pathology.
- Patients with lvPPA must have at least mild to moderate language impairment.
- Patients with aMCI must meet criteria for this condition, including the presence of at least mild to moderate episodic memory impairment.
- Patients must be native English speakers.
Key exclusion criteria (6 listed)
- Any history of seizures, unexplained loss of consciousness or a first-degree family member with epilepsy (to ensure safety to receive rTMS).
- Any history of significant co-occurring neurological illness unrelated to the neurodegenerative disease in question (e.g. multiple sclerosis), or significant medical problems (e.g. poorly controlled diabetes/hypertension or cancer within 5 years).
- Active symptoms of major depressive disorder, bipolar disorder, schizophrenia, substance use disorder or significant premorbid intellectual disability according to DSM criteria.
- MRI evidence of significant (e.g. confluent leukoariosis or stroke) cerebrovascular disease, hydrocephalus or the presence of a space-occupying intra-cranial mass.
- Contraindications to MRI or rTMS including: cardiac pacemaker or pacemaker wires, neurostimulators, implanted pumps, metal in the body (rods, plates, screws, shrapnel, dentures, IUD), surgical aneurysm clips in the head, previous neurosurgery or cochlear implants.
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 |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS)rTMS is a method to focally and reversibly stimulate a pre-specified cortical target. rTMS works through the principle of electromagnetic induction. | Device | Active stimulation, SHAM stimulation |
Primary outcome
Boston Naming Test
Time frame: Up to 5 weeks
A test of confrontation naming of drawn pictures.
Western Aphasia Battery-repetition
Time frame: Up to 5 weeks
A test of the ability to repeat phonetically complex phrases
Western Aphasia Battery-reading comprehension
Time frame: Up to 5 weeks
A test of the ability to correctly comprehend read material
Western Aphasia Battery-spelling
Time frame: Up to 5 weeks
A test of the ability to spell irregular words.
Controlled Oral Word Association Test
Time frame: Up to 5 weeks
A test of word generation, e.g. generation of as many words as possible beginning with a certain letter of the alphabet.
Cambridge Semantic Battery
Time frame: Up to 5 weeks
A test of semantic knowledge through word-pairings.
The Northwestern Anagram Test
Time frame: Up to 5 weeks
A test of non-verbal production of sentences.
Picture Description Test
Time frame: Up to 5 weeks
A test in which patients write a paragraph describing a picture, such as a picnic or the cookie theft picture.
Changes in intrinsic functional connectivity
Time frame: Up to 5 weeks
Changes in region-to-region functional connectivity within the stimulated networks will be assessed, e.g. changes in connectivity in the DMN will be assessed in aMCI patients and changes in the language network will be assessed in lvPPA patients.
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 17 Mar 2022.
- Individual participant dataSharing planned: No. There is no plan to share IPD with researchers outside of this protocol.
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Aging
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 repetitive transcranial magnetic stimulation (rTMS) in people with Alzheimer Disease and Primary Progressive Aphasia, run by Brigham and Women's Hospital at 1 site in United States.
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 6 inclusion and 6 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 17 Mar 2022. 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 United States. 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 (time frame: Up to 5 weeks). The study lists 9 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 17 Mar 2022.