Clinical Trial: NOn-invasive Repeated THerapeutic STimulation for Aphasia Recovery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: NOn-invasive Repeated THerapeutic STimulation for Aphasia Recovery

Brief Summary:

The current standard of care for rehabilitation of patients with aphasia after stroke is conventional speech and language therapy (SLT). Due to economic realities on most stroke units, SLT can often not be given with optimal intensity in the first weeks after the stroke. Developing new adjuvant therapies which may render SLT sessions more effective is thus one approach to improve rehabilitation outcome. Recent functional imaging studies in post-stroke aphasia have shown that the recruitment of brain regions in the unaffected hemisphere seems to be an inferior strategy for recovery of language function as compared to re-activation of brain regions in the vicinity of the infarct. Non-invasive brain stimulation techniques, such as repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) are new methods to modulate brain activity. Evidence from our own feasibility study in sub-acute stroke suggests that these new techniques, when applied in conjunction with conventional SLT, may help to normalize brain activation patterns and might yield better rehabilitation outcome than SLT alone. With NORTHSTAR, we propose a multicenter proof-of-concept study to investigate the safety, feasibility and efficacy of these new non-invasive brain stimulation methods as adjuvant therapies for subacute post-stroke aphasia.

Our goal is to determine the most effective brain stimulation modality to decrease inhibition onto the left side of the brain. We will assess if a combination of brain stimulation and speech and language therapy will improve language recovery. We will quantify language recovery (expressive and comprehensive skills) using specific tests, commonly used by speech and language therapists.

We will invite patients recently admitted to the stroke unit of the study centers to participate in o

Detailed Summary:

Aim 1: To test the hypothesis that any type of non-invasive brain stimulation in combination with conventional SLT results in better aphasia recovery at 1 and 30 days after end of treatment than SLT with sham stimulation.

Aim 2: To test the hypothesis that tDCS in combination with SLT is non-inferior to rTMS in combination with SLT but both are superior to SLT with sham stimulation.

Aim 3: To test the hypothesis that there will be no difference in the frequency of adverse events between the treatment groups.

Aim 4: To test the hypothesis that there is a differential influence of attention, time to treatment, infarct location and bilingualism on the treatment effect.

Aim 5: To test the hypothesis that the extent of functional and structural connectivity between the stimulation site over the triangular part of the right inferior frontal gyrus and the left hemisphere primary language centers determines effectiveness of the therapy.

Description of study population

Additional information: The eligibility criteria have been selected such that the resulting study population will reflect a typical clinical population of aphasic stroke patients. Stroke location and aphasia type are thus not inclusion or exclusion criterion but will be documented in order to ensure a similar distribution between treatment groups and allow for subgroup analysis.

Study design

Additional information: All patients will receive 45 minutes of model-oriented individualized aphasia therapy administered by a certified therapist and focused on the individual specif
Sponsor: Dr. Alexander Thiel

Current Primary Outcome:

• Change from baseline in verbal fluency on the Verbal fluency test at 1 and 30 days after completion of the treatment period [ Time Frame: at baseline, 1 and 30 days after completion of the treatment period ]
  Verbal fluency test
• Change from baseline in language comprehension on the Token test at 1 and 30 days after completion of the treatment period [ Time Frame: at baseline, 1 and 30 days after completion of the treatment period ]
  Token test
• Cumulative number of Adverse Events and Serious Adverse Events during 10 days of therapy [ Time Frame: at each days of treatment ]
  Cumulative number of Adverse Effects and Serious Adverse Effects during 10 days of therapy
• Change from baseline in naming ability on the Boston naming test at 1 and 30 days after completion of the treatment period [ Time Frame: at baseline, 1 and 30 days after completion of the treatment period ]
  Boston Naming Test
• Cumulative number of Adverse Events and Serious Adverse Events during 30 days following completion of the treatment [ Time Frame: at each day during 30 days following completion of the treatment ]
  Cumulative number of Adverse Events and Serious Adverse Events during 30 days following completion of the treatment

Original Primary Outcome: Same as current

Current Secondary Outcome: Change from baseline in Aphasia global test scores on standard aphasia test batteries at 1 and 30 days after completion of the treatment period [ Time Frame: at baseline, 1 and 30 days after completion of the treatment period ]

Original Secondary Outcome: Same as current

Information By: Thiel, Alexander, M.D.

Dates:
Date Received: December 10, 2013
Date Started: December 2013
Date Completion:
Last Updated: November 7, 2016
Last Verified: November 2016