NCT01007136

Brief Summary

The purpose is to determine whether application of a non-invasive battery powered device called transcranial direct current stimulation (tDCS) can improve recovery of hand weakness after stroke beyond what is achievable with rehabilitative treatment alone.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

September 22, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

5 years

First QC Date

November 2, 2009

Results QC Date

November 14, 2019

Last Update Submit

September 18, 2020

Conditions

Ischemic Stroke

Keywords

tDCSstrokefunctional MRITMS

Outcome Measures

Primary Outcomes (3)

  • Upper Extremity Fugl-Meyer

    Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.

    2 weeks

  • Upper Extremity Fugl-Meyer

    Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.

    3 months

  • Upper Extremity Fugl-Meyer

    Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.

    1 year after stroke

Secondary Outcomes (1)

  • Wolf Motor Function Test

    3 months

Other Outcomes (10)

  • Visual Analog Pain Scale

    during therapy

  • Mini Mental Status Scale

    3 months

  • NIHSS

    3 months

  • +7 more other outcomes

Study Arms (2)

tDCS and occupational therapy

EXPERIMENTAL

1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.

Device: tDCS

Sham and occupational therapy

SHAM COMPARATOR

Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.

Device: Sham tDCS

Interventions

tDCSDEVICE

1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.

Also known as: Transcranial Direct Current Stimulation, Electric stimulation
tDCS and occupational therapy
Sham tDCSDEVICE

Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.

Sham and occupational therapy

Eligibility Criteria

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

You may qualify if:

  • ischemic stroke causing arm weakness within 5-15 days
  • no other neurological or psychiatric disease, who are able to perform study tasks

You may not qualify if:

  • patients younger than 18 or older than 80 years
  • patients with more than one disabling stroke
  • Patients with bilateral motor impairment
  • Patients with poor motivational capacity, history of severe alcohol or drug abuse
  • Patients with severe language disturbances, particularly of receptive nature
  • Patients with serious cognitive deficits (defined as equivalent to a MMS score of 23 or less)
  • Patients with severe uncontrolled medical problems (e.g., seizures, progressive stroke syndromes, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age or others),
  • Patients with unstable thyroid disease
  • Patients with increased intracranial pressure
  • Patients with unstable cardiac arrhythmia
  • Patients with contraindication to TMS or tDCS stimulation (pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull, patients who had a craniotomy, skin lesions at the site of stimulation)
  • Patients who are not available for follow-up at 3 and 12 months
  • Pregnancy
  • Patients with contraindication to MRI will not participate in MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (4)

  • Hidler J, Hodics T, Xu B, Dobkin B, Cohen LG. MR compatible force sensing system for real-time monitoring of wrist moments during fMRI testing. J Neurosci Methods. 2006 Sep 15;155(2):300-7. doi: 10.1016/j.jneumeth.2006.01.016. Epub 2006 Feb 21.

    PMID: 16490258BACKGROUND

  • 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: 22579647BACKGROUND

  • Hodics T, Cohen LG, Pezzullo JC, Kowalske K, Dromerick AW. Barriers to Enrollment in Post-Stroke Brain Stimulation in a Racially and Ethnically Diverse Population. Neurorehabil Neural Repair. 2022 Sep;36(9):596-602. doi: 10.1177/15459683221088861. Epub 2022 Aug 4.

    PMID: 35925037DERIVED

  • 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

MeSH Terms

Conditions

Ischemic StrokeStroke

Interventions

Transcranial Direct Current StimulationElectric 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 TechniquesPhysical StimulationInvestigative Techniques

Limitations and Caveats

Slow recruitment and termination before pre-specified number of subjects recruited, attrition due to being lost to follow-up.

Results Point of Contact

Title
Timea Hodics, M.D.
Organization
University of Texas Southwestern
Timea.Hodics@UTSouthwestern.edu

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 2, 2009

First Posted

November 3, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

September 22, 2020

Results First Posted

September 22, 2020

Record last verified: 2020-09

Locations

US(1)