Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia

NCT01277575 | Terminated Phase 3

• 1 other identifier: EBS-PP-2010-08-25-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Aphasia

Keywords

stroke; aphasia; language

Outcome Measures

Primary Outcomes (1)

• improvement of speaking

  assessed by the following tests: * Expressive speaking: ANELT (Amsterdam Nijmegen Everyday Language Test), Aachener Aphasie Test * receptive speaking: ANELT (Amsterdam Nijmegen Everyday Language Test), Aachener Aphasie Test

  between baseline and 60 days after stimulation

Secondary Outcomes (6)

• successful stabilization of language

  60 days after stimulation

• speaking functions 1 - communicative skills

  baseline to 60 days after stimulation

• speaking functions 2 - spontaneous speech faculty

  baseline to 60 days after stimulation

• speaking functions 3 - naming

  baseline to 60 days after stimulation

• speaking functions 4 - repeating

  baseline to 60 days after stimulation

Study Arms (2)

Verum stimulation

EXPERIMENTAL

repetitive transorbital alternating current stimulation (rtACS)

Device: rtACS stimulation (Verum condition)

Placebo stimulation

SHAM COMPARATOR

Sham stimulation (placebo condition) no intervention

Device: placebo condition

Interventions

rtACS stimulation (Verum condition) DEVICE

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

Verum stimulation

placebo condition DEVICE

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).

Placebo stimulation

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stroke
• lesion age at least 6 months
• aphasia with at least moderate severity according to Aachener Aphasia Test (AAT)
• age between 40 and 75
• German-speaking (at a native speaking level)

You may not qualify if:

• cognitive or speech-language therapy during the 2-weeks stimulation course
• intensive language training when exceeding 1 hour, 2 times a week during the 2-weeks stimulation course and the follow-up period (60 days after stimulation was completed)
• additional neurological diseases, e.g. surgical brain tumor removal, untreated tumor disease, acute traumatic brain injury, and/or craniotomy
• (severe) dysarthria
• untreated hypertension exceeding 160/100 mmHg (patients with treated hypertension and blood pressure below 160/100 mmHg can be included)
• increased risk of vascular thrombosis
• epilepsy, photo sensitivity, acute focal findings (patients without focal findings or epileptiform discharges can be included when they had only a single seizure more than 10 years ago)
• dementias and neurodegenerative diseases
• significant psychiatric disturbances, e.g. schizophrenia
• major attention and/or memory deficits
• major hearing loss
• patients with uncorrected visual deficits
• severe global aphasia
• modality-specific disorders (pure speech apraxia, pure alexia, pure agraphia)
• electric or electronic implants (e.g. heart pacemakers)

Sponsors & Collaborators

• University of Magdeburg: lead
• EBS Technologies GmbH: collaborator

Study Sites (3)

Neurologische Klinik, Medizinische Fakultät der RWTH Aachen, Pauwelsstr. 30

Aachen, 52074, Germany

Location

Neurologische Klinik, Brandenburg Klinik Bernau, Brandenburgallee 1

Bernau Waldsiedlung, 16321, Germany

Location

Institut für Medizinische Psychologie, Leipziger Str. 44

Magdeburg, 39120, Germany

Location

MeSH Terms

Conditions

Aphasia; Stroke; Language

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Communication; Behavior

Study Officials

• Bernhard A Sabel, Prof. Dr.

  University of Magdeburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 17, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 19, 2013

Record last verified: 2011-01

Locations

DE (3)