Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia

Terminated

Phase 3 Results N/A

Trial Description

The investigators assess if repetitive, transcranial alternating current stimulation (rtACS) can improve the speaking quality of the aphasic patient as well as other communication skills as naming, repeating and understanding spoken words, reading and writing. Further, it will be assessed if memory and attentiveness deficiencies after 10 days of therapy with brain stimulation are stabilized and remain stable after a training-free period of 60 days.

Trial Stopped: recruitment efforts did not result in a sufficient number of patients

Conditions

Interventions

  • RtACS stimulation (Verum condition) Device
    Intervention Desc: Repetitive, transorbital alternating current stimulation (rtACS) is applied with multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse is below 1000 microA. Current intensity is individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation
    ARM 1: Kind: Experimental
    Label: Verum stimulation
    Description: repetitive transorbital alternating current stimulation (rtACS)
  • Placebo condition Device
    Intervention Desc: A clicking sound is presented and the same electrode montage set-up is used during rtASC- and Placebo-stimulation, except that placebo patients received no current (stimulator turned off).
    ARM 1: Kind: Experimental
    Label: Placebo stimulation
    Description: Sham stimulation (placebo condition) no intervention

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary improvement of speaking between baseline and 60 days after stimulation No
Secondary successful stabilization of language 60 days after stimulation No
Secondary speaking functions 1 - communicative skills baseline to 60 days after stimulation No
Secondary speaking functions 2 - spontaneous speech faculty baseline to 60 days after stimulation No
Secondary speaking functions 3 - naming baseline to 60 days after stimulation No
Secondary speaking functions 4 - repeating baseline to 60 days after stimulation No
Secondary speaking functions 5 - understanding baseline to 60 days after stimulation No

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