Transcranial Direct Current Stimulation (tDCS) in Chronic Stroke Recovery

April 9, 2020 updated by: University of Texas Southwestern Medical Center

tDCS in Chronic Stroke Recovery-pilot

The hypothesis of this study is that different subgroups of stroke will respond differently to direct current stimulation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

We have tested the effectiveness of each stimulation condition: 1) anodal over the lesional motor cortex 2) anodal PMD (positive electrode at the dorsal premotor cortex (PMD) of the lesional hemisphere (first phase) or dual motor cortex stimulation (second phase), 3) cathodal over the contralesional motor cortex, and 4) sham in a double blind crossover design in chronic cortical and subcortical strokes.

Persons in the chronic stage of recovery from stroke (>3 months) will receive each type of tDCS stimulation for 20 minutes concurrent with physical therapy treatments (90 minutes ) utilizing the Armeo ®, a gravity neutral arm exercise support system for the most involved upper extremity which provides for task practice in a virtual reality environment, followed by a therapist supervised targeted hand exercise. The experimental protocol will not alter standard of care, will be performed after standard rehabilitation is completed. The experimental therapy is not part of standard care and will not be charged or reimbursed by the patients' insurance. Participation will be free of charge for subjects.

We were planning to perform the study in two phases. In the first exploratory phase, we will conduct a short pilot study with 15 subjects to optimize and if possible simplify the treatment parameters for the second longer phase of the experiment. In this first phase we will perform one of the four different tDCS stimulation conditions concurrently with the physical therapy protocol on each therapy day, so that all subjects will receive all stimulation types in a randomized counterbalanced order. There will be a 1 day rest period in between sessions, making 9 days (10 days if initial evaluation is done on the day before the 1st treatment) the total commitment time for the first phase of study.

The outcome measures were collected before and after each session. The outcome measures collected after the 1 day rest provide the baseline for the next session will be also used as to validate the stability of the treatment effect. Subjects participating in the first part of the study will be offered the option to participate in the second longer phase of the study. (please see table under study procedures)

In the second phase of the experiment we will perform only the promising stimulation paradigms plus sham from the first part of the experiment in a random, counterbalanced order on up to 30 chronic stroke subjects. If in the initial phase there are no differences found between stimulation types in the cortical vs subcortical patient groups then all 3 stimulation paradigms will be performed in the second phase.

Based on our preliminary data, we will perform the following paradigms in the second phase: 1) sham 2) dual stimulation 3) optimized tDCS in a randomized counterbalanced order. The optimized tDCS will be determined during a test session prior to the first treatment where the tDCS montage producing the best behavioral response will be used during therapy. Subjects will perform this under IRB approved study # STU 102013-085.

The patient time commitment in the second phase is 18 weeks, where subjects will have 3 x 1 weeks long treatment (5 weekdays) sessions with 5 week inter-treatment "rest period". The blinded tester will perform a final outcome evaluation 5 weeks after the end of the last session. (please see table under study procedures)

Total number of potential enrolled subjects for both phases will be approximately 45 [Phase 1 (15) + Phase 2 (30)].

The stepwise design will enable us to optimize study time commitment and expenses for both patients and researchers while maximizing clinical/scientific gain.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • single symptomatic stroke more than 3 months ago with hand/arm weakness
  • able to perform required tests and provide consent
  • Age 18-80
  • Modified Ashworth scale <3
  • range of motion functional at shoulder elbow wrist and hand

Exclusion Criteria:

  • more than one symptomatic stroke in middle cerebral artery territory or bilateral involvement
  • severe medical or psychiatric conditions, drug abuse, seizure disorder
  • pregnancy/breast feeding
  • subarachnoid hemorrhage, lobar hemorrhage
  • patients who can not have tDCS (prior head surgery, pacemakers, metallic implants in the head etc)
  • patients taking antiadrenergic medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: subcortical
Subcortical stroke patients will receive tDCS stimulation and sham in random order
Device: tDCS
tDCS and sham will be applied in random order during standardized occupational therapy
Other Names:
  • transcranial direct current stimulation
EXPERIMENTAL: cortical
subjects will receive active and sham tDCS in random order
Device: tDCS
tDCS and sham will be applied in random order during standardized occupational therapy
Other Names:
  • transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Wolf Motor Function test
Time Frame: immediately before and immediately after treatment
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks. The WMFT has been posited as instructive for assessing the motor status of higher functioning chronic patients with stroke and traumatic brain injury, in terms of severity and upper extremity motor deficiency. The final time score will be the median time required for all timed tasks executed. One hundred twenty seconds is the maximum time allowed for each task attempted. Since medians will be used, all scores above the median (whether, e.g., 62 sec. or 120+ sec.) have the same weight
immediately before and immediately after treatment
Fugl-Meyer Assessment
Time Frame: immediately before and immediately after treatment
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226, though it is common practice to assess all domains separately <50 = severe impairment, 50-84 = marked impairment, 85-94 = moderate impairment, 95-99= slight impairment
immediately before and immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Timea Hodics, M.D., UTSW

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2009

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 032009-067
  • 092010-231 (OTHER: UTSW IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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