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Dual Transcranial Direct Current Stimulation (dTDCS)-Enhanced Therapy After Hemorrhagic Strokes and VEGF

Primary Purpose

Hemorrhagic Stroke, Hemiparesis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dual transcranial direct current stimulation
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhagic Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dTDCS plus physical therapy

Sham dTDCS plus physical therapy

Arm Description

active dual transcranial direct current stimulation (TDCS) arm (M1-M1)

Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used.

Outcomes

Primary Outcome Measures

Adverse Events
any adverse events that might be related to study procedures
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).

Secondary Outcome Measures

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)

Full Information

First Posted
June 21, 2017
Last Updated
October 29, 2019
Sponsor
University of Texas Southwestern Medical Center
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT03857243
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Due to administrative difficulties caused by PI change.
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
April 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Stroke, Hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dTDCS plus physical therapy
Arm Type
Experimental
Arm Description
active dual transcranial direct current stimulation (TDCS) arm (M1-M1)
Arm Title
Sham dTDCS plus physical therapy
Arm Type
Placebo Comparator
Arm Description
Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used.
Intervention Type
Device
Intervention Name(s)
dual transcranial direct current stimulation
Other Intervention Name(s)
dtDCS,, dual tDCS
Intervention Description
Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed.
Primary Outcome Measure Information:
Title
Adverse Events
Description
any adverse events that might be related to study procedures
Time Frame
enrollment to 3 month followup
Title
Upper Extremity Fugl-Meyer Score
Description
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
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dual Transcranial Direct Current Stimulation (dTDCS)-Enhanced Therapy After Hemorrhagic Strokes and VEGF

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