Ischemic StrokeNCT01007136

Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery

A study testing tDCS in people with Ischemic Stroke, run by University of Texas Southwestern Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Ischemic Stroke
What is being tested?: tDCS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 62 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Mar 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Southwestern Medical Center
Dallas, Texas, 75390

Other trials in United States

About this study

Official title: TDCS-enhanced Stroke Recovery and Cortical Reorganization

Conditions: Ischemic Stroke
Being tested: tDCS, Sham tDCS
Keywords: tDCS, stroke, functional MRI, TMS
Medical subject headings: Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tDCSDevice
Also called Transcranial Direct Current Stimulation, Electric stimulation
1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical 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.

Study groups in NCT01007136
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

Upper Extremity Fugl-Meyer
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
Measured: 2 weeks
Upper Extremity Fugl-Meyer
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
Measured: 3 months
Upper Extremity Fugl-Meyer
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
Measured: 1 year after stroke

Secondary outcomes (1)

Wolf Motor Function Test
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability determined through the use of timed and functional tasks. The score represents the average speed the subject could perform of the timed motor tasks.
The score is the average of the scores calculated from "how many times would a person have completed the task, had he or she been performing it continuously for 60 seconds". The score ranges from 0 to no theoretical maximum, with higher numbers meaning faster/ better performance. (See publication Dr. Hodics et al. 2012.)
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Mar 2014

First posted3 Nov 2009 (estimated)
Study startMar 2009
Primary completionMar 2014
Study completionMar 2014

Why it stopped: Funding limit reached due to slower then anticipated recruitment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01007136
Sponsor's protocol ID: STU 092010-231
Other IDs: K23HD050267
Status last verified: Sep 2020
First submitted: 2 Nov 2009
Last updated: 22 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 16490258
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.
PubMed 22579647
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.
PubMed 35925037
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.
PubMed 33175411

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TDCS-enhanced Stroke Recovery and Cortical Reorganization
ClinicalTrials.gov ID: NCT01007136
Acronym / sponsor ID: STU 092010-231
Conditions: Ischemic Stroke
Keywords: tDCS, stroke, functional MRI, TMS
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funding limit reached due to slower then anticipated recruitment.
Enrolment: 62 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Mar 2009
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 3 Nov 2009 (estimated)
Results: Posted 22 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
tDCS and occupational therapy	Experimental	Device: tDCS1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.
Sham and occupational therapy	Sham comparator	Device: Sham tDCSElectric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tDCSAlso: Transcranial Direct Current Stimulation, Electric stimulation1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Device	tDCS and occupational therapy
Sham tDCSElectric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	Device	Sham and occupational therapy

Primary outcome

Upper Extremity Fugl-Meyer
Time frame: 2 weeks
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
Upper Extremity Fugl-Meyer
Time frame: 3 months
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
Upper Extremity Fugl-Meyer
Time frame: 1 year after stroke
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.

1 secondary outcome

Wolf Motor Function Test
Time frame: 3 months

Results and safety

Results posted to the registry on 22 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
tDCS and Occupational Therapy	19	15
Sham and Occupational Therapy	17	13
fMRI Control Group no Intervention	15	15
tDCS and no Arm Movement	6	6
Sham and no Arm Movement	4	4

Primary outcome: Upper Extremity Fugl-Meyer

Time frame: 2 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	tDCS and Occupational Therapy n = 15	Sham and Occupational Therapy n = 13	tDCS and no Arm Movement n = 6	Sham and no Arm Movement n = 4
Value	30.2 (21.2)	36.8 (22.4)	8.2 (10.2)	4.5 (1)

Population analysed: All subjects with outcome data at the prespecified follow-up timepoint were included. "fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.

Primary outcome: Upper Extremity Fugl-Meyer

Time frame: 3 months. Mean (Standard Deviation). Unit: units on a scale

Measure	tDCS and Occupational Therapy n = 10	Sham and Occupational Therapy n = 11	tDCS and no Arm Movement n = 3	Sham and no Arm Movement n = 1
Value	32.4 (24.5)	47.7 (18.7)	9.7 (9.8)	4.0 (0.0)

Primary outcome: Upper Extremity Fugl-Meyer

Time frame: 1 year after stroke. Mean (Standard Deviation). Unit: units on a scale

Measure	tDCS and Occupational Therapy n = 5	Sham and Occupational Therapy n = 9	tDCS and no Arm Movement n = 0	Sham and no Arm Movement n = 1
Value	32.6 (29.2)	56.0 (12.8)	–	4.0 (0.0)

Population analysed: All subjects with outcome data at the prespecified follow-up timepoint were included.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year, the entire time of follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
tDCS and Occupational Therapy	2 of 19 (10.5%)	9 of 19 (47.4%)	1 of 19
Sham and Occupational Therapy	2 of 17 (11.8%)	3 of 17 (17.6%)	0 of 17
fMRI Control Group no Intervention	0 of 15 (0%)	0 of 15 (0%)	0 of 15
tDCS and no Arm Movement	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Sham and no Arm Movement	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): Slow recruitment and termination before pre-specified number of subjects recruited, attrition due to being lost to follow-up.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16490258Hidler 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.
Background: PubMed 22579647Hodics 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.
Derived from this study: PubMed 35925037Hodics 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.
Derived from this study: PubMed 33175411Elsner 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing tDCS in people with Ischemic Stroke, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Upper Extremity Fugl-Meyer (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01007136, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020; AzTrials last refreshed its copy on 30 Oct 2026.