Interhemispheric Inhibitory Interactions

NCT01371409 | Completed

• 2 other identifiers: H09-00368CIHR
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

After a stroke the excitability of the brain decreases on the stroke side and increases on the opposite, non-stroke side. These changes make use of the stroke-affected arm difficult and slow recovery. Rehabilitation exercises that increase arm use after stroke help increase brain excitability, but the net effect of this approach is low. New therapies are needed that restore more equal levels of brain excitability between the two sides. Brain stimulation is a noninvasive way to affect activity the excitability of brain cells. Pairing brain stimulation with exercises that require patients to learn new movements may help the brain to learn. Using stimulation that reduces activity in the side opposite to the stroke can increase activity on the stroke -affected side, through connections between the two brain hemispheres. The purpose of this study is to test if brain stimulation on the side opposite to the stroke, paired with arm movement exercises, can help patients learn new arm movements and improve arm function. In this study people with stroke will receive brain stimulation over two different areas on the side of the brain opposite to the stroke: 1) those areas responsible for movement and 2) those responsible for sensation. These experiments will test both the short and long term effects of brain stimulation on patients' learning and arm function and will allow us to identify which area of the brain best improves learning and arm function. These experiments have the potential to improve the effectiveness of rehabilitation after stroke. The proposed study is among the first to test stimulation over the side of the brain opposite to the stroke damage and at multiple sites. This unique approach may help stimulate the development of new methods for stroke rehabilitation.

Conditions

Stroke

Keywords

Stroke; TMS; Paired Pulse; EEG; Motor Learning

Outcome Measures

Primary Outcomes (1)

• Response Time

  Response time on a custom designed serial tracking program

  change from baseline to day 6

Secondary Outcomes (6)

• Wolf Motor

  change from baseline to day 6

• Limb Position Matching

  change from baseline to day 6

• Intracortical Inhibition

  change from baseline to day 6

• Movement Time

  change from baseline to day 6

• Movement Trajectory

  change from baseline to day 6

Study Arms (2)

active cTBS

EXPERIMENTAL

Other: continuous theta burst stimulation

Sham cTBS

SHAM COMPARATOR

Other: continuous theta burst stimulation

Interventions

continuous theta burst stimulation OTHER

80% active motor threshold, 600 pulses

Also known as: transcranial magnetic stimulation

Sham cTBS; active cTBS

Eligibility Criteria

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

You may qualify if:

• aged 40-75
• single, MCA territory stroke
• at least 6 months post stroke
• Fugl-Meyer (upper extremity) score of 15-55

You may not qualify if:

• absence of TMS motor evoked potential
• score \<24 on the Montreal Cognitive Assessment
• history of seizure/epilepsy, head trauma, major psychiatric diagnosis
• aphasic (score \<13 on Frenchay Aphasia Screen)
• contraindications to TMS/MRI

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 2B5, Canada

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Lara A Boyd, PT, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 10, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2016
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

CA (1)