NCT01014897

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at P25-P50 for phase_1 stroke

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_1 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2009

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 17, 2009

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

7.5 years

First QC Date

November 2, 2009

Last Update Submit

April 9, 2020

Conditions

Stroke

Keywords

strokerecoverytDCSdirect currentelectric stimulation

Outcome Measures

Primary Outcomes (2)

  • Wolf Motor Function test

    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

    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

Study Arms (2)

subcortical

EXPERIMENTAL

Subcortical stroke patients will receive tDCS stimulation and sham in random order

Device: tDCS

cortical

EXPERIMENTAL

subjects will receive active and sham tDCS in random order

Device: tDCS

Interventions

tDCSDEVICE

tDCS and sham will be applied in random order during standardized occupational therapy

Also known as: transcranial direct current stimulation
corticalsubcortical

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (2)

  • Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

    PMID: 33175411DERIVED

  • Hodics TM, Nakatsuka K, Upreti B, Alex A, Smith PS, Pezzullo JC. Wolf Motor Function Test for characterizing moderate to severe hemiparesis in stroke patients. Arch Phys Med Rehabil. 2012 Nov;93(11):1963-7. doi: 10.1016/j.apmr.2012.05.002. Epub 2012 May 10.

    PMID: 22579647DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Timea Hodics, M.D.

    UTSW

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2009

First Posted

November 17, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)