NOn-invasive Repeated THerapeutic STimulation for Aphasia Recovery
NORTHSTAR
1 other identifier
interventional
63
3 countries
6
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2013
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 10, 2013
CompletedFirst Posted
Study publicly available on registry
December 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedOctober 26, 2021
October 1, 2021
4.2 years
December 10, 2013
October 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change from baseline in verbal fluency on the Verbal fluency test at 1 and 30 days after completion of the treatment period
Verbal fluency test
at baseline, 1 and 30 days after completion of the treatment period
Change from baseline in language comprehension on the Token test at 1 and 30 days after completion of the treatment period
Token test
at baseline, 1 and 30 days after completion of the treatment period
Cumulative number of Adverse Events and Serious Adverse Events during 10 days of therapy
Cumulative number of Adverse Effects and Serious Adverse Effects during 10 days of therapy
at each days of treatment
Change from baseline in naming ability on the Boston naming test at 1 and 30 days after completion of the treatment period
Boston Naming Test
at baseline, 1 and 30 days after completion of the treatment period
Cumulative number of Adverse Events and Serious Adverse Events 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
at each day during 30 days following completion of the treatment
Secondary Outcomes (1)
Change from baseline in Aphasia global test scores on standard aphasia test batteries at 1 and 30 days after completion of the treatment period
at baseline, 1 and 30 days after completion of the treatment period
Study Arms (3)
rTMS
EXPERIMENTALParticipants will receive real rTMS and sham tDCS
tDCS
EXPERIMENTALParticipants will receive real tDCS and sham rTMS
Sham
SHAM COMPARATORParticipants will receive both sham rTMS and sham tDCS
Interventions
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.
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.
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Burke-Cornell Medical Research Institute
White Plains, New York, 10605, United States
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
Toronto Rehabilitation Institute - UHN
Toronto, Ontario, M5G 2C4, Canada
CHUM Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Max-Planck-Institut für neurologische Forschung
Cologne, 50931, Germany
Related Publications (2)
Zumbansen A, Black SE, Chen JL, J Edwards D, Hartmann A, Heiss WD, Lanthier S, Lesperance P, Mochizuki G, Paquette C, Rochon EA, Rubi-Fessen I, Valles J, Kneifel H, Wortman-Jutt S, Thiel A; NORTHSTAR-study group. Non-invasive brain stimulation as add-on therapy for subacute post-stroke aphasia: a randomized trial (NORTHSTAR). Eur Stroke J. 2020 Dec;5(4):402-413. doi: 10.1177/2396987320934935. Epub 2020 Jun 30.
PMID: 33598559BACKGROUNDZumbansen A, Kneifel H, Lazzouni L, Ophey A, Black SE, Chen JL, Edwards D, Funck T, Hartmann AE, Heiss WD, Hildesheim F, Lanthier S, Lesperance P, Mochizuki G, Paquette C, Rochon E, Rubi-Fessen I, Valles J, Wortman-Jutt S, Thiel A; NORTHSTAR-study group. Differential Effects of Speech and Language Therapy and rTMS in Chronic Versus Subacute Post-stroke Aphasia: Results of the NORTHSTAR-CA Trial. Neurorehabil Neural Repair. 2022 Apr;36(4-5):306-316. doi: 10.1177/15459683211065448. Epub 2022 Mar 25.
PMID: 35337223DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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)
- PRINCIPAL INVESTIGATOR
Dylan Edwards, Ph.D.
Burke-Cornell Medical Research Institute (New-York)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Alexander Thiel, MD, Associate Professor.
Study Record Dates
First Submitted
December 10, 2013
First Posted
December 24, 2013
Study Start
December 1, 2013
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
October 26, 2021
Record last verified: 2021-10