StrokePhase 1/2NCT02249819

Evaluating Anodal tDCS Preceding Aphasia Therapy

A Phase 1/2 study testing transcranial direct current stimulation in people with Stroke and Aphasia, run by Northwell Health 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 of this study is to determine if non-invasive brain stimulation (transcranial direct current stimulation) delivered prior to language therapy will improve word-finding in individuals with aphasia who are 6 months or greater post-stroke. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke, Aphasia
What is being tested?: transcranial direct current stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Sep 2014to Nov 2017
Phase: Phase 1/2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 18 years of age
First single focal unilateral left hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
Pre-morbidly right handed
Pre-morbidly fluent English speaker
Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist)
A baseline Aphasia Quotient score between 10 to 94 out of 100 points on the Western Aphasia Battery (neither completely without language comprehension/expression nor fully recovered from aphasia).

Who cannot join

Ongoing use of CNS-active medications
Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
Presence of additional potential tDCS risk factors:
Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system
Metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation)

Show all 9Show fewer

A history of medication-resistant epilepsy in the family
Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months
Pregnancy in women, as determined by self-report

Trial locations and contacts

1 site in 1 country.

United States1 site

Feinstein Institute for Medical Research
Manhasset, New York, 11030

Other trials in United States

About this study

Conditions: Stroke, Aphasia
Being tested: transcranial direct current stimulation
Keywords: stroke, aphasia, CVA, apraxia, cerebrovascular accident, cerebral stroke, speech therapy, aphasia therapy, non-invasive brain stimulation, transcranial direct current stimulation, tDCS
Medical subject headings: Stroke, Aphasia, Apraxias, Communication Disorders

What participants receive

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

transcranial direct current stimulationDevice
Soterix 1x1 anodal tDCS

Study groups in NCT02249819
Study group	Role	What they receive
anodal tDCS, then sham tDCS	Experimental	Participants received 1 single 20 min session of anodal tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of sham tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants. Receives: Device: transcranial direct current stimulation
sham tDCS, then anodal tDCS	Experimental	Participants received 1 single 20 min session of sham tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of anodal tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants. Receives: Device: transcranial direct current stimulation

What is being measured

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

Mean Change in Picture-naming Accuracy Score
The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).
Measured: baseline, discharge

Timeline

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

Sep 2014Nov 2017

First posted26 Sep 2014 (estimated)
Study startSep 2014
Primary completionJun 2017
Study completionNov 2017

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 (5)Papers the sponsor has linked to this study.
Other trials for 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: All participants received both stimulation conditions (active tDCS + computerized naming therapy and sham tDCS + computerized naming therapy), separated by a 1-week washout period.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02249819
Sponsor's protocol ID: 14-416
Status last verified: Feb 2019
First submitted: 23 Sep 2014
Last updated: 5 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Monti A, Cogiamanian F, Marceglia S, Ferrucci R, Mameli F, Mrakic-Sposta S, Vergari M, Zago S, Priori A. Improved naming after transcranial direct current stimulation in aphasia. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):451-3. doi: 10.1136/jnnp.2007.135277. Epub 2007 Dec 20.
PubMed 18096677
Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.
PubMed 20395612
Fiori V, Coccia M, Marinelli CV, Vecchi V, Bonifazi S, Ceravolo MG, Provinciali L, Tomaiuolo F, Marangolo P. Transcranial direct current stimulation improves word retrieval in healthy and nonfluent aphasic subjects. J Cogn Neurosci. 2011 Sep;23(9):2309-23. doi: 10.1162/jocn.2010.21579. Epub 2010 Oct 14.
PubMed 20946060
Holland R, Crinion J. Can tDCS enhance treatment of aphasia after stroke? Aphasiology. 2012 Sep;26(9):1169-1191. doi: 10.1080/02687038.2011.616925. Epub 2011 Nov 3.
PubMed 23060684
Marangolo P, Fiori V, Campana S, Calpagnano MA, Razzano C, Caltagirone C, Marini A. Something to talk about: enhancement of linguistic cohesion through tdCS in chronic non fluent aphasia. Neuropsychologia. 2014 Jan;53:246-56. doi: 10.1016/j.neuropsychologia.2013.12.003. Epub 2013 Dec 11.
PubMed 24333381

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 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating Anodal tDCS Preceding Aphasia Therapy
ClinicalTrials.gov ID: NCT02249819
Acronym / sponsor ID: 14-416
Conditions: Stroke, Aphasia
Keywords: stroke, aphasia, CVA, apraxia, cerebrovascular accident, cerebral stroke, speech therapy, aphasia therapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 15 participants (actual)
Lead sponsor: Northwell HealthUniversity, hospital or other
Study start: Sep 2014 (actual)
Primary completion: Jun 2017 (actual)
Study completion: Nov 2017 (actual)
First posted: 26 Sep 2014 (estimated)
Results: Posted 6 Apr 2018

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: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: All participants received both stimulation conditions (active tDCS + computerized naming therapy and sham tDCS + computerized naming therapy), separated by a 1-week washout period.

Arm	Type	Receives
anodal tDCS, then sham tDCS	Experimental	Device: transcranial direct current stimulationParticipants received 1 single 20 min session of anodal tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of sham tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants.
sham tDCS, then anodal tDCS	Experimental	Device: transcranial direct current stimulationParticipants received 1 single 20 min session of sham tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of anodal tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

≥ 18 years of age
First single focal unilateral left hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
Pre-morbidly right handed
Pre-morbidly fluent English speaker
Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist)

Key exclusion criteria (9 listed)

Ongoing use of CNS-active medications
Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
Presence of additional potential tDCS risk factors:
Pregnancy in women, as determined by self-report

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
transcranial direct current stimulationSoterix 1x1 anodal tDCS	Device	anodal tDCS, then sham tDCS, sham tDCS, then anodal tDCS

Primary outcome

Mean Change in Picture-naming Accuracy Score
Time frame: baseline, discharge
The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).

Results and safety

Results posted to the registry on 6 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anodal tDCS, Then Sham tDCS	8	8
Sham tDCS, Then Anodal tDCS	7	7

Primary outcome: Mean Change in Picture-naming Accuracy Score

Time frame: baseline, discharge. Mean (Standard Deviation). Unit: score

Measure	Anodal tDCS n = 15	Sham tDCS n = 15
Mean Score at Discharge(out of 75)	51.33 (17.79)	51.00 (18.40)
Mean Change from Baseline	5.25 (4.85)	5.92 (5.21)

Anodal tDCS vs Sham tDCS: p = 0.694, wilcoxon sign-ranked test

Population analysed: All participants received one dose of each intervention and completed all study visits. They were consequently all included in the efficacy analysis.

Adverse events

Time frame: Two weeks for each intervention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anodal tDCS	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Sham tDCS	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18096677Monti A, Cogiamanian F, Marceglia S, Ferrucci R, Mameli F, Mrakic-Sposta S, Vergari M, Zago S, Priori A. Improved naming after transcranial direct current stimulation in aphasia. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):451-3. doi: 10.1136/jnnp.2007.135277. Epub 2007 Dec 20.
Background: PubMed 20395612Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.
Background: PubMed 20946060Fiori V, Coccia M, Marinelli CV, Vecchi V, Bonifazi S, Ceravolo MG, Provinciali L, Tomaiuolo F, Marangolo P. Transcranial direct current stimulation improves word retrieval in healthy and nonfluent aphasic subjects. J Cogn Neurosci. 2011 Sep;23(9):2309-23. doi: 10.1162/jocn.2010.21579. Epub 2010 Oct 14.
Background: PubMed 23060684Holland R, Crinion J. Can tDCS enhance treatment of aphasia after stroke? Aphasiology. 2012 Sep;26(9):1169-1191. doi: 10.1080/02687038.2011.616925. Epub 2011 Nov 3.
Background: PubMed 24333381Marangolo P, Fiori V, Campana S, Calpagnano MA, Razzano C, Caltagirone C, Marini A. Something to talk about: enhancement of linguistic cohesion through tdCS in chronic non fluent aphasia. Neuropsychologia. 2014 Jan;53:246-56. doi: 10.1016/j.neuropsychologia.2013.12.003. Epub 2013 Dec 11.
Individual participant dataSharing planned: Undecided

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Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
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Not yet recruitingObservational study
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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 Phase 1/2 study testing transcranial direct current stimulation in people with Stroke and Aphasia, run by Northwell Health 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 6 inclusion and 9 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 5 Apr 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2018). 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?

Mean Change in Picture-naming Accuracy Score (time frame: baseline, discharge). 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 NCT02249819, which also lists 5 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 5 Apr 2021.