Effect of Stimulation of the Prefrontal Cortex on Language Production in Aphasic Patients

Aphasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840370
• Other study ID #: SNF325130_156937_3
• Status: Completed
• Phase: N/A
• First received: July 19, 2016
• Last updated: October 24, 2017
• Start date: May 2016
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: University of Fribourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background:

Language processing is a complex brain function supported by a large network, including domain-specific language areas as well as domain-general cognitive-control networks (Friederici & Gierhan, 2013). Noninvasive brain stimulation, such as transcranial direct current stimulation (tDCS), is increasingly being used as a promising therapeutic tool for psychiatric and neurological diseases (Tortella et al., 2015; Flöel, 2014). In the language domain, several studies revealed that tDCS over languagespecific areas induces changes in cortical function that enhances the recovery of language abilities in patients with post-stroke aphasia (Torres, Drebing & Hamilton, 2013; Monti et al., 2013). Beneficial effects of tDCS have also been found for stimulation over more domain-general cognitive control regions. Although research on non-invasive brain stimulation and aphasia reveals promising results, studies investigating the modulation of cognitive control-networks on lexical access are rare. Given the importance of a successful interplay between prefrontal and domain-specific language areas, possible therapeutic effects of tDCS over the prefrontal cortex (PFC) in aphasia can be of high value for rehabilitation and basic research.

Procedure:

A planned total of 30 patients will be included. In a first visit, the severity of aphasia, the medical history as well as inclusion/exclusion criteria will be evaluated. After this visit, patients will undergo two tDCS sessions (one tDCS and one S-tDCS session) with a one week interval between the sessions. Each session consists of an online (during stimulation) and an offline assessment (within 30 minutes after stimulation). Three language tasks and a nonverbal executive function task will be conducted online as well as offline in each of the two sessions (tDCS and S-tDCS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aphasia

Intervention

Device:
• transcranial direct current stimulation
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.
• Sham tDCS
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.

Locations

Country	Name	City	State
Switzerland	Hôpital Cantonal de Fribourg	Fribourg
Switzerland	Laboratory for Cognitive and Neurological Sciences	Fribourg
Switzerland	University Hospital Geneva	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
Jean-Marie Annoni	Hôpital Cantonal de Fribourg, University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Flöel 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. Review. — View Citation

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. Review. — View Citation

Monti 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. Review. — View Citation

Torres 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. Review. — View Citation

Tortella G, Casati R, Aparicio LV, Mantovani A, Senço 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Language production	Picture naming task, repetition task and verbal fluency task	up to 30 min
Secondary	Nonverbal executive functions task		up to 30 min