Effect of Stimulation of the Prefrontal Cortex on Language Production in Aphasic Patients
Effect of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Language Production in Aphasic Patients: a Multicentre Experimental Study With a Placebo-controlled and Double Blind Crossover Design
1 other identifier
interventional
19
1 country
3
Brief Summary
The purpose of this study is to investigate whether transcranial direct current stimulation (tDCS) of the prefrontal cortex (PFC) influences lexical access and language production. The experimental paradigm will assess the impact of prefrontal stimulation by tDCS versus sham tDCS (S-tDCS) over the PFC of patients with chronic post-stroke aphasia during three language production tasks and a nonverbal executive functions task.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 19, 2016
CompletedFirst Posted
Study publicly available on registry
July 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedOctober 26, 2017
October 1, 2017
10 months
July 19, 2016
October 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Language production
Picture naming task, repetition task and verbal fluency task
up to 30 min
Secondary Outcomes (1)
Nonverbal executive functions task
up to 30 min
Study Arms (2)
transcranial direct current stimulation
EXPERIMENTALtDCS
Sham tDCS
SHAM COMPARATORS-tDCS
Interventions
In tDCS, the prefrontal cortex is stimulated during 20minutes through a weak constant electric current (1-2 mA) through two electrodes in a non-invasive and painless manner.
S-tDCS refers to a control condition in which the subject will receive a brief current in the beginning in order to induce a similar sensation on the scalp as in tDCS, and then the stimulator remains off for the rest of the stimulation time.
Eligibility Criteria
You may qualify if:
- Chronic aphasia due to ischemic or haemorrhagic stroke (\> 6 months post-stroke)
- French as dominant language
- Right-handedness
- Left hemisphere lesion with intact bilateral PFC
You may not qualify if:
- Diagnosed dementia or psychiatric comorbidity
- Epileptic seizure within the last 12 months
- Metallic head implants
- Pacemaker
- Inability to understand procedures or insufficient language production abilities
- pregnancy
- strong headache on the days of the tDCS sessions
- consumption of alcohol and/or unprescribed drugs on the days of the tDCS sessions or on the day before
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jean-Marie Annonilead
- University Hospital, Genevacollaborator
- Hôpital Cantonal de Fribourgcollaborator
Study Sites (3)
Laboratory for Cognitive and Neurological Sciences
Fribourg, 1700, Switzerland
Hôpital Cantonal de Fribourg
Fribourg, 1708, Switzerland
University Hospital Geneva
Geneva, 1206, Switzerland
Related Publications (5)
Friederici AD, Gierhan SM. The language network. Curr Opin Neurobiol. 2013 Apr;23(2):250-4. doi: 10.1016/j.conb.2012.10.002. Epub 2012 Nov 9.
PMID: 23146876BACKGROUNDTortella G, Casati R, Aparicio LV, Mantovani A, Senco N, D'Urso G, Brunelin J, Guarienti F, Selingardi PM, Muszkat D, Junior Bde S, Valiengo L, Moffa AH, Simis M, Borrione L, Brunoni AR. Transcranial direct current stimulation in psychiatric disorders. World J Psychiatry. 2015 Mar 22;5(1):88-102. doi: 10.5498/wjp.v5.i1.88.
PMID: 25815258BACKGROUNDFloel A. tDCS-enhanced motor and cognitive function in neurological diseases. Neuroimage. 2014 Jan 15;85 Pt 3:934-47. doi: 10.1016/j.neuroimage.2013.05.098. Epub 2013 May 30.
PMID: 23727025BACKGROUNDTorres J, Drebing D, Hamilton R. TMS and tDCS in post-stroke aphasia: Integrating novel treatment approaches with mechanisms of plasticity. Restor Neurol Neurosci. 2013;31(4):501-15. doi: 10.3233/RNN-130314.
PMID: 23719561BACKGROUNDMonti A, Ferrucci R, Fumagalli M, Mameli F, Cogiamanian F, Ardolino G, Priori A. Transcranial direct current stimulation (tDCS) and language. J Neurol Neurosurg Psychiatry. 2013 Aug;84(8):832-42. doi: 10.1136/jnnp-2012-302825. Epub 2012 Nov 8.
PMID: 23138766BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Marie Annoni, Prof. Dr.
University of Fribourg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
July 19, 2016
First Posted
July 21, 2016
Study Start
May 1, 2016
Primary Completion
March 1, 2017
Study Completion
September 1, 2017
Last Updated
October 26, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share