Hemorrhagic StrokeNCT03857243
Dual Transcranial Direct Current Stimulation (dTDCS)-Enhanced Therapy After Hemorrhagic Strokes and VEGF
A study testing dual transcranial direct current stimulation in people with Hemorrhagic Stroke and Hemiparesis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study will evaluate the feasibility of dual tDCS to improve arm motor function in chronic stroke patients. In addition it will collect pilot data on the blood biomarkers associated with treatment effect. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhagic Stroke, Hemiparesis
- What is being tested?
- dual transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 17 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients (18-85 yo) with arm weakness (uFM <60) as a result of an ICH and no history of other neurologic or psychiatric illness that are able to activate wrist flexors (> MRC 1);
- Patients with symptomatic ICH >5 months before enrollment;
- Ashworth spasticity score <3.
Who cannot join
- Patients with severe uncontrolled medical problems,
- Patients with subarachnoid, subdural or epidural hemorrhage;
- Patients with unstable cardiac arrhythmia;
- Patients with contraindication to tDCS stimulation;
- Patients who are not available for follow-up or unable to follow study procedures;
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
This study will evaluate the feasibility of dual tDCS to improve arm motor function in chronic stroke patients. In addition it will collect pilot data on the blood biomarkers associated with treatment effect.
Read the detailed description
The proposed, increased intensity dtDCS is a new, economical, noninvasive stimulation approach that has the potential for large-scale clinical application. Dual tDCS, in conjunction with physical and occupational therapy, is not only more effective in enhancing motor performance and cortical plasticity compared to sham, but approximately 50% more effective than cathodal or anodal stimulation in healthy subjects and after stroke. However, it will only be clinically useful and important if the beneficial effects persist over time in a wider stroke patient population. Improvement in inter-hemispheric balance, through an activation shift toward the affected hemisphere and clinical improvement in response to tDCS has been reported previously in small studies. Hemorrhagic stroke patients have not been evaluated.
The investigators will study rehabilitation associated cortical plasticity at a cellular level to gain insight into the neural substrates underlying the clinical improvement. There are no prior studies investigating the potential of VEGF polymorphisms to contribute to rehabilitative treatment-induced functional recovery in humans. The investigators expect that patients with VEGF genotype 2578A/A will recover less then subjects without this polymorphism. Since in animal models VEGF and BDNF have a complimentary role, VEGF polymorphism may explain some of the variability in strength of association between BDNF polymorphism Val66Met and recovery. This novel pilot study measures both the genetic and physiologic expression of multiple growth factors - before and after a promising new therapy regimen - to better understand the contribution of growth factors to long-term plasticity and functional recovery. If VEGF serum levels elevate with clinical improvement, then this may identify a new indicator of treatment efficacy that can be collected noninvasively and with little cost. The results will provide guidance for new inclusion/exclusion criteria for clinical studies based on genetic markers, as well as uncover the potential for new therapeutic strategies to enhance treatment efficacy by augmenting VEGF during rehabilitation with FDA-approved strategies currently in clinical trials for other conditions (NIH Clinical Trials Registry: NCT01384162, NCT00620217, and NCT00744315).
- Conditions
- Hemorrhagic Stroke, Hemiparesis
- Being tested
- dual transcranial direct current stimulation
- Medical subject headings
- Hemorrhagic Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual transcranial direct current stimulationDevice
Also called dtDCS,, dual tDCS
Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed.
| Study group | Role | What they receive |
|---|---|---|
| dTDCS plus physical therapy | Experimental | active dual transcranial direct current stimulation (TDCS) arm (M1-M1) Receives: Device: dual transcranial direct current stimulation |
| Sham dTDCS plus physical therapy | Placebo comparator | Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used. Receives: Device: dual transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
any adverse events that might be related to study procedures
Measured: enrollment to 3 month followup
Upper Extremity Fugl-Meyer Score
Upper extremity motor impairment scale. Scale ranges from 0 (worst, can not perform any tasks) to 66 ( performs all tasks fully).
Measured: change between before and 3 months follow-up
Secondary outcomes (1)
Wolf Motor Function Test
Timed performance of 15 functional upper extremity tasks, 0-120 seconds, and 2 strength measures.
WMFT time measurements are calculated as the arithmetic mean of rate of performance, where we calculate "how many times would a person have completed the task, had he or she been performing it continuously for 60 seconds". Therefore the results have a minimum score of 0, where the subject could not perform any of the tasks, and no pre-defined maximum score, the higher the rate score the faster the subject was able to perform the tasks. ( see Hodics et al.,2013)
Measured: change between before and at 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study startJan 2014
- Primary completionDec 2016
- Study completion17 Apr 2017
Why it stopped: Due to administrative difficulties caused by PI change.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemorrhagic StrokeStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857243
- Sponsor's protocol ID
- 14GRNT18690039
- Other IDs
- STU 012014-028
- Status last verified
- Oct 2019
- First submitted
- 21 Jun 2017
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Transcranial Direct Current Stimulation (dTDCS)-Enhanced Therapy After Hemorrhagic Strokes and VEGF
- ClinicalTrials.gov ID
- NCT03857243
- Acronym / sponsor ID
- 14GRNT18690039
- Conditions
- Hemorrhagic Stroke, Hemiparesis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to administrative difficulties caused by PI change.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- 17 Apr 2017 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Posted 18 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the feasibility of dual tDCS to improve arm motor function in chronic stroke patients. In addition it will collect pilot data on the blood biomarkers associated with treatment effect.
Detailed description
The proposed, increased intensity dtDCS is a new, economical, noninvasive stimulation approach that has the potential for large-scale clinical application. Dual tDCS, in conjunction with physical and occupational therapy, is not only more effective in enhancing motor performance and cortical plasticity compared to sham, but approximately 50% more effective than cathodal or anodal stimulation in healthy subjects and after stroke. However, it will only be clinically useful and important if the beneficial effects persist over time in a wider stroke patient population. Improvement in inter-hemispheric balance, through an activation shift toward the affected hemisphere and clinical improvement in response to tDCS has been reported previously in small studies. Hemorrhagic stroke patients have not been evaluated.
The investigators will study rehabilitation associated cortical plasticity at a cellular level to gain insight into the neural substrates underlying the clinical improvement. There are no prior studies investigating the potential of VEGF polymorphisms to contribute to rehabilitative treatment-induced functional recovery in humans. The investigators expect that patients with VEGF genotype 2578A/A will recover less then subjects without this polymorphism. Since in animal models VEGF and BDNF have a complimentary role, VEGF polymorphism may explain some of the variability in strength of association between BDNF polymorphism Val66Met and recovery. This novel pilot study measures both the genetic and physiologic expression of multiple growth factors - before and after a promising new therapy regimen - to better understand the contribution of growth factors to long-term plasticity and functional recovery. If VEGF serum levels elevate with clinical improvement, then this may identify a new indicator of treatment efficacy that can be collected noninvasively and with little cost. The results will provide guidance for new inclusion/exclusion criteria for clinical studies based on genetic markers, as well as uncover the potential for new therapeutic strategies to enhance treatment efficacy by augmenting VEGF during rehabilitation with FDA-approved strategies currently in clinical trials for other conditions (NIH Clinical Trials Registry: NCT01384162, NCT00620217, and NCT00744315).
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 |
|---|---|---|
| dTDCS plus physical therapy | Experimental | Device: dual transcranial direct current stimulationactive dual transcranial direct current stimulation (TDCS) arm (M1-M1) |
| Sham dTDCS plus physical therapy | Placebo comparator | Device: dual transcranial direct current stimulationNon-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients (18-85 yo) with arm weakness (uFM <60) as a result of an ICH and no history of other neurologic or psychiatric illness that are able to activate wrist flexors (> MRC 1);
- Patients with symptomatic ICH >5 months before enrollment;
- Ashworth spasticity score <3.
Key exclusion criteria (6 listed)
- Patients with severe uncontrolled medical problems,
- Patients with subarachnoid, subdural or epidural hemorrhage;
- Patients with unstable cardiac arrhythmia;
- Patients with contraindication to tDCS stimulation;
- Patients who are not available for follow-up or unable to follow study procedures;
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 |
|---|---|---|
| dual transcranial direct current stimulationAlso: dtDCS,, dual tDCSMild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed. | Device | Sham dTDCS plus physical therapy, dTDCS plus physical therapy |
Primary outcome
Adverse Events
Time frame: enrollment to 3 month followup
any adverse events that might be related to study procedures
Upper Extremity Fugl-Meyer Score
Time frame: change between before and 3 months follow-up
Upper extremity motor impairment scale. Scale ranges from 0 (worst, can not perform any tasks) to 66 ( performs all tasks fully).
1 secondary outcome
Wolf Motor Function Test
Time frame: change between before and at 3 months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hemorrhagic Stroke
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Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
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Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
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Thrombolysis in Factor Xa-inhibitors Trial
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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 dual transcranial direct current stimulation in people with Hemorrhagic Stroke and Hemiparesis, run by University of Texas Southwestern Medical Center 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 3 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: stopped early, as of the sponsor's last update on 18 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 18 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events (time frame: enrollment to 3 month followup). The study lists 2 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 18 Nov 2019.