Dual Transcranial Direct Current Stimulation (dTDCS)-Enhanced Therapy After Hemorrhagic Strokes and VEGF
Status: | Terminated |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 3/1/2019 |
Start Date: | January 2014 |
End Date: | April 17, 2017 |
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.
chronic stroke patients. In addition it will collect pilot data on the blood biomarkers
associated with treatment effect.
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. We 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).
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. We 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).
Inclusion Criteria:
1. 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);
2. Patients with symptomatic ICH >5 months before enrollment;
3. Ashworth spasticity score <3.
Exclusion Criteria:
1. Patients with severe uncontrolled medical problems,
2. Patients with subarachnoid, subdural or epidural hemorrhage;
3. Patients with unstable cardiac arrhythmia;
4. Patients with contraindication to tDCS stimulation;
5. Patients who are not available for follow-up or unable to follow study procedures;
6. Pregnancy
We found this trial at
1
site
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
Click here to add this to my saved trials