StrokeNCT05198037
Clinical Implications of FKBP5 in Stroke
A study testing Bihemispheric tDCS in people with Stroke, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
With contemporary lifestyle changes and global aging, it is important yet unknown how stress interacts to post-stroke outcomes. This proposal aims to study the link between the stress-responsive FKBP51-related pathways and neural plasticity after stroke, elucidating FKBP5 gene polymorphisms and blood FKBP51 regulation… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Bihemispheric tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2021to Jul 2025
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral ischemic or hemorrhagic stroke
- Aged 20-80 years old
Who cannot join
- FMA-UE is over 49 points
- Major psychiatric diseases
- Major neurologic diseases
- Global aphasia
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
I-Hui Lee, MD, PhD, 886-2-28712121 ext. 8109, ihlee@vghtpe.gov.tw
I-Hui Lee, MD, PhD
About this study
Official title: Clinical Implications of FKBP5 in Post-stroke Neural Plasticity and Neuromodulation Effects
With contemporary lifestyle changes and global aging, it is important yet unknown how stress interacts to post-stroke outcomes. This proposal aims to study the link between the stress-responsive FKBP51-related pathways and neural plasticity after stroke, elucidating FKBP5 gene polymorphisms and blood FKBP51 regulation in relation to brain excitability and functions, understanding the effects of transcranial direct current stimulation, and characterizing brain mechanisms for individualized early rehabilitation after stroke.
Read the detailed description
Stress is an underestimated risk factor and also a consequence of cardiovascular diseases and stroke. FK506-binding protein 51 (FKBP51) modulates stress responses by acting as a co-chaperone that negatively regulates glucocorticoid receptor (GR) to cortisol binding and nuclear signaling. In an oxygen-glucose deprivation (OGD) model of acute mouse hippocampal slices, FKBP5 deletion reduced ischemic neuronal hyperexcitation, and cathodal electrical stimulation of OGD-injured wild-type decreased FKBP51 levels. However, clinical implications of FKBP5 polymorphisms and FKBP51 regulation in post-stroke outcomes and neuromodulation-induced plasticity are unknown. We aim to assess the link between FKBP5 polymorphisms and blood FKBP51 regulation after stroke, and their relationship with stroke phenotypes, brain connectivity and functional outcomes.
- Conditions
- Stroke
- Being tested
- Bihemispheric tDCS
- Keywords
- Stroke, FKBP5, Motor, Transcranial direct current stimulation, Plasticity, Stress
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bihemispheric tDCSDevice
The anode and cathode are placed over the ipsilesional and contralesional primary motor cortex (C3 or C4 based on 10-20 system), respectively. The size of the electrode is 5x5 cm.
| Study group | Role | What they receive |
|---|---|---|
| Active transcranial direct current stimulation (tDCS) | Experimental | Weak direct currents with 2 mA are delivered 20 minutes per session (including 30s ramp-up and 30s ramp-down) during tailored upper extremity task practice. Total sessions are 20 over 10 days. Receives: Device: Bihemispheric tDCS |
| Sham tDCS | Sham comparator | The device is automatically shut down after 2-minute stimulation. Treatment sessions and frequency are the same as the Experimental arm. Receives: Device: Bihemispheric tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment of Upper Extremity, FMA-UE
Motor recovery of upper extremity poststroke
Measured: Change score from baseline (~10 days poststroke) to 90 days poststroke
Secondary outcomes (4)
Action Research Arm Test, ARAT
Motor function of upper extremity poststroke
Measured: Change score from baseline (~10 days poststroke) to 90 days poststroke
Fugl-Meyer Assessment of Lower Extremity, FMA-LE
Motor recovery of lower extremity poststroke
Measured: Change score from baseline (~10 days poststroke) to 90 days poststroke
Perceived Stress Scale-10
Stress level poststroke
Measured: Change score from baseline (~10 days poststroke) to 90 days poststroke
Protein and gene test
Protein expression poststroke and identifying genotypes of participants
Measured: Change score from baseline (~10 days poststroke) to 90 days poststroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Nov 2021
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Anticipated 100 participants are assigned to the experimental or sham-controlled groups with an allocation rate of 1:1, for the clinical trial. In addition, another group of patients participates in the observational study (no intervention).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198037
- Sponsor's protocol ID
- 2021-02-002C
- Status last verified
- Jan 2022
- First submitted
- 23 Nov 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implications of FKBP5 in Post-stroke Neural Plasticity and Neuromodulation Effects
- ClinicalTrials.gov ID
- NCT05198037
- Acronym / sponsor ID
- 2021-02-002C
- Conditions
- Stroke
- Keywords
- Stroke, FKBP5, Motor, Transcranial direct current stimulation, Plasticity, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 20 Jan 2022 (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.
With contemporary lifestyle changes and global aging, it is important yet unknown how stress interacts to post-stroke outcomes. This proposal aims to study the link between the stress-responsive FKBP51-related pathways and neural plasticity after stroke, elucidating FKBP5 gene polymorphisms and blood FKBP51 regulation in relation to brain excitability and functions, understanding the effects of transcranial direct current stimulation, and characterizing brain mechanisms for individualized early rehabilitation after stroke.
Detailed description
Stress is an underestimated risk factor and also a consequence of cardiovascular diseases and stroke. FK506-binding protein 51 (FKBP51) modulates stress responses by acting as a co-chaperone that negatively regulates glucocorticoid receptor (GR) to cortisol binding and nuclear signaling. In an oxygen-glucose deprivation (OGD) model of acute mouse hippocampal slices, FKBP5 deletion reduced ischemic neuronal hyperexcitation, and cathodal electrical stimulation of OGD-injured wild-type decreased FKBP51 levels. However, clinical implications of FKBP5 polymorphisms and FKBP51 regulation in post-stroke outcomes and neuromodulation-induced plasticity are unknown. We aim to assess the link between FKBP5 polymorphisms and blood FKBP51 regulation after stroke, and their relationship with stroke phenotypes, brain connectivity and functional outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Anticipated 100 participants are assigned to the experimental or sham-controlled groups with an allocation rate of 1:1, for the clinical trial. In addition, another group of patients participates in the observational study (no intervention).
| Arm | Type | Receives |
|---|---|---|
| Active transcranial direct current stimulation (tDCS) | Experimental | Device: Bihemispheric tDCSWeak direct currents with 2 mA are delivered 20 minutes per session (including 30s ramp-up and 30s ramp-down) during tailored upper extremity task practice. Total sessions are 20 over 10 days. |
| Sham tDCS | Sham comparator | Device: Bihemispheric tDCSThe device is automatically shut down after 2-minute stimulation. Treatment sessions and frequency are the same as the Experimental arm. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral ischemic or hemorrhagic stroke
- Aged 20-80 years old
Key exclusion criteria (4 listed)
- FMA-UE is over 49 points
- Major psychiatric diseases
- Major neurologic diseases
- Global aphasia
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 |
|---|---|---|
| Bihemispheric tDCSThe anode and cathode are placed over the ipsilesional and contralesional primary motor cortex (C3 or C4 based on 10-20 system), respectively. The size of the electrode is 5x5 cm. | Device | Active transcranial direct current stimulation (tDCS), Sham tDCS |
Primary outcome
Fugl-Meyer Assessment of Upper Extremity, FMA-UE
Time frame: Change score from baseline (~10 days poststroke) to 90 days poststroke
Motor recovery of upper extremity poststroke
4 secondary outcomes
Action Research Arm Test, ARAT
Time frame: Change score from baseline (~10 days poststroke) to 90 days poststroke
Fugl-Meyer Assessment of Lower Extremity, FMA-LE
Time frame: Change score from baseline (~10 days poststroke) to 90 days poststroke
Perceived Stress Scale-10
Time frame: Change score from baseline (~10 days poststroke) to 90 days poststroke
Protein and gene test
Time frame: Change score from baseline (~10 days poststroke) to 90 days poststroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bihemispheric tDCS in people with Stroke, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 4 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: status not confirmed, as of the sponsor's last update on 20 Jan 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-Hui Lee, MD, PhD (+ 886-2-28712121 ext. 8109, ihlee@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment of Upper Extremity, FMA-UE (time frame: Change score from baseline (~10 days poststroke) to 90 days poststroke). 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 20 Jan 2022.