Hemiparesis, Hemorrhagic Stroke
Conditions
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).
Interventions
DEVICEdual transcranial direct current stimulation
Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed.
Sponsors
American Heart Association
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | enrollment to 3 month followup | any adverse events that might be related to study procedures |
| Upper Extremity Fugl-Meyer Score | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wolf Motor Function Test | change between before and at 3 months follow-up | 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) |
Countries
United States
Participant flow
Pre-assignment details
3 subjects were found not eligible for participation after signing consent.
Participants by arm
| Arm | Count |
|---|---|
| dTDCS Plus Physical Therapy active dual transcranial direct current stimulation (TDCS) arm (M1-M1)
dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed. | 1 |
| Sham dTDCS Plus Physical Therapy Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used.
dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed. | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | dTDCS Plus Physical Therapy | Sham dTDCS Plus Physical Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White/Nonhispanic | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Adverse Events
any adverse events that might be related to study procedures
Time frame: enrollment to 3 month followup
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| dTDCS Plus Physical Therapy | Adverse Events | 0 number of events |
| Sham dTDCS Plus Physical Therapy | Adverse Events | 0 number of events |
Primary
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).
Time frame: change between before and 3 months follow-up
Population: One subject finished the treatment, statistical analysis was not performed
Secondary
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)
Time frame: change between before and at 3 months follow-up
Population: One subject finished the treatment, statistical analysis was not performed