DRKS00011116.

Trial name or title	Effects of transcranial direct current stimulation (tDCS) on patients with apraxia of speech: a combined tDCS‐fMRI study
Methods	RCT
Participants	Estimated enrolment: 40 Inclusion criteria: aged between 18 and 80 years, first‐ever ischaemic stroke of the left cerebral hemisphere; chronic phase of the disease: > 6 months post onset; presence of apraxia of speech as diagnosed by speech and language therapist as well as neurologist; right‐handed; German as native language Exclusion criteria: severe aphasia with language comprehension < 25 in the relevant subtest of the AAT; left‐handedness; contraindications for tDCS (e.g. epilepsy); contraindications for MRI; no/reduced compliance; participation in clinical trial in the last 3 months
Interventions	2 arms: ‐ Dual tDCS with the cathode placed over F7‒F5 right and the anode placed over F7‒F5 left, employing 20 minutes of 2 mA, in addition to conventional speech and language therapy (SLT), every day for 2 weeks ‐ S‐tDCS with the cathode placed over F7‒F5 right and the anode placed over F7‒F5 left. The current will be switched off after 20 seconds, rendering the intervention without effect, every day for 2 weeks
Outcomes	Primary outcomes: ‐ improvements in language abilities in the verum cohort as opposed to the sham cohort. Improvements will be measured using the Hierarchical Word Lists in the week prior to the first week of therapy and the week following the last therapeutic session (week 3) Secondary outcomes: ‐ improvements in other linguistic domains in the verum cohort as opposed to the sham cohort. These endpoints will be assessed using the AAT (Aachener Aphasie Test), a novel test measuring apraxia of speech and a formal test of diadochokinesis. Test points will be the week prior and the week after therapy (week 3) ‐ quality of life: the Aachen Quality of Life Inventory will be applied in the week prior to therapy and 20 weeks after therapy ‐ neuronal marker correlating with linguistic improvements. Structural (Diffusion tensor imaging) and fMRI (task based: spontaneous speech, diadochokinesis; resting state fMRI) will be employed prior to therapy and in the week after therapy (week 3)
Starting date	4 August 2017
Contact information	Uniklinik RWTH Aachen, Klinik für Neurologie Mr Dr med Cornelius J Werner Pauwelsstraße 30 52074 Aachen Germany Telephone: 0241‐8089600 E‐mail: cwerner at ukaachen.de
Notes