NOn-invasive Repeated THerapeutic STimulation for Aphasia Recovery (NORTHSTAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Thiel, Alexander, M.D.
Sponsor:
Information provided by (Responsible Party):
Dr. Alexander Thiel, Thiel, Alexander, M.D.
ClinicalTrials.gov Identifier:
NCT02020421
First received: December 10, 2013
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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 our research project. Once patients consent to our study we will randomly assign them to one of three experimental groups. For 12 days, all groups of patients will be setup with brain stimulation during their usual rehabilitation sessions. Two of those groups (treatment groups) will each receive a different type of brain stimulation (rTMS and tDCS), in the third group, patients will not receive real stimulation (placebo group). By comparing the extent of aphasia recovery between groups, we will determine the benefits attributable to brain stimulation relative to SLT alone.


Condition Intervention
Aphasia
Device: rTMS
Device: tDCS
Device: Sham rTMS
Device: Sham tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: NOn-invasive Repeated THerapeutic STimulation for Aphasia Recovery

Resource links provided by NLM:


Further study details as provided by Thiel, Alexander, M.D.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Token test

  • Cumulative number of Adverse Events and Serious Adverse Events during 10 days of therapy [ Time Frame: at each days of treatment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Cumulative number of Adverse Events and Serious Adverse Events during 30 days following completion of the treatment


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Western Aphasia Battery, Montréal-Toulouse 86, Aachener Aphasie Test


Estimated Enrollment: 90
Study Start Date: December 2013
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rTMS
Participants will receive real rTMS and sham tDCS
Device: rTMS
Low frequency (1Hz) repetitive transcranial magnetic stimulation (rTMS) over the center of the right Pars Triangularis for 15 minutes (900 pulses) prior to each Speech-Language therapy session. Stimulation intensity will be set at 90% of the resting motor threshold (RMT) of the left first dorsal interosseous (FDI) muscle.
Device: Sham tDCS
Sham cathodal transcranial direct current stimulation (tDCS) over the right Pars Triangularis. The anode will be placed on the forehead over the contralateral eye. To elicit the typical skin sensation of real tDCS (tingling sensation on the skin when tDCS is turned on and off), the current will be turned on for 30 seconds and then turned off for the duration of the speech-language therapy session. The same procedure will be done at the end of the session.
Experimental: tDCS
Participants will receive real tDCS and sham rTMS
Device: tDCS
2mA cathodal transcranial direct current stimulation (tDCS) over the right Pars Triangularis. The anode will be placed on the forehead over the contralateral eye. tDCS will start immediately before the speech-language therapy session and last throughout the session.
Device: Sham rTMS
Low frequency (1Hz) repetitive transcranial magnetic stimulation (rTMS) over the Vertex for 15 minutes (900 pulses) prior to each Speech-Language therapy session. Stimulation intensity will be set at 10% of the resting motor threshold (RMT) of the left first dorsal interosseous (FDI) muscle.
Sham Comparator: Sham
Participants will receive both sham rTMS and sham tDCS
Device: Sham rTMS
Low frequency (1Hz) repetitive transcranial magnetic stimulation (rTMS) over the Vertex for 15 minutes (900 pulses) prior to each Speech-Language therapy session. Stimulation intensity will be set at 10% of the resting motor threshold (RMT) of the left first dorsal interosseous (FDI) muscle.
Device: Sham tDCS
Sham cathodal transcranial direct current stimulation (tDCS) over the right Pars Triangularis. The anode will be placed on the forehead over the contralateral eye. To elicit the typical skin sensation of real tDCS (tingling sensation on the skin when tDCS is turned on and off), the current will be turned on for 30 seconds and then turned off for the duration of the speech-language therapy session. The same procedure will be done at the end of the session.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ischemic stroke in the left MCA territory
  • between 5 and 30 days post stroke
  • right-handedness
  • English, French or German as language of daily use
  • score below the lower limit of the norm on at least one of the primary outcome measures

Exclusion Criteria:

  • prior symptomatic ischemic or hemorrhagic stroke
  • severe comprehension deficit that may compromise informed consent or understanding of instructions
  • contraindications to MRI and/or TMS/tDCS
  • neurodegenerative or psychiatric disease
  • epilepsy or EEG-documented epileptic discharges
  • chronic renal or liver failure
  • life-threatening diseases
  • auditory or visual deficits that cannot be corrected and might impair testing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02020421

Contacts
Contact: Anna Zumbansen, MPO 514-340-8222 ext 4289 azumbansen@jgh.mcgill.ca

Locations
Canada, Ontario
Sunnybrook Research Institute Recruiting
Toronto, Ontario, Canada, M4N 3M5
Principal Investigator: Sandra Black, M.D.         
Toronto Rehabilitation Institute - UHN Recruiting
Toronto, Ontario, Canada, M5G 2C4
Principal Investigator: Elizabeth Rochon, Ph.D.         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Principal Investigator: Alexander Thiel, M.D.         
CHUM Notre-Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Principal Investigator: Sylvain Lanthier, M.D.         
Germany
Max-Planck-Institut für neurologische Forschung Recruiting
Köln, Germany, 50931
Principal Investigator: Wolf-Dieter Heiss, M.D.         
Sponsors and Collaborators
Dr. Alexander Thiel
Investigators
Principal Investigator: Alexander Thiel, M.D. Jewish General Hospital (Montreal, Quebec)
Principal Investigator: Sandra Black, M.D. Sunnybrook Research Institute (Toronto, Ontario)
Principal Investigator: Elizabeth Rochon, Ph.D. Toronto Rehabilitation Institute - UHN
Principal Investigator: Sylvain Lanthier, M.D. Hôpital Notre-Dame (Montreal, Quebec)
Principal Investigator: Wolf-Dieter Heiss, M.D. Max-Planck-Institut fur Neurologische Forschung (Cologne, Germany)
  More Information

No publications provided

Responsible Party: Dr. Alexander Thiel, Alexander Thiel, MD, Associate Professor., Thiel, Alexander, M.D.
ClinicalTrials.gov Identifier: NCT02020421     History of Changes
Other Study ID Numbers: NORTHSTAR
Study First Received: December 10, 2013
Last Updated: April 9, 2014
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Germany: Ethics Commission

Keywords provided by Thiel, Alexander, M.D.:
ischemic stroke
rehabilitation
aphasia
non-invasive brain stimulation

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014