Clinical trial NCT03857243: Dual Transcranial Direct Current Stimulation (dTDCS)-Enhanced Therapy After Hemorrhagic Strokes and VEGF
Official title: Dual Transcranial Direct Current Stimulation (dTDCS)-Enhanced Therapy After Hemorrhagic Strokes and VEGF
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemorrhagic Stroke
Hemiparesis
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2019-02-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: enrollment to 3 month followup
measure: Upper Extremity Fugl-Meyer Score
timeFrame: change between before and 3 months follow-up
Secondary outcomes:
measure: Wolf Motor Function Test
timeFrame: change between before and at 3 months follow-up
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References: