Sleep as a Model to Understand and Manipulate Cortical Activity in Order to Promote Functional Recovery After Stroke

Not Applicable

Completed

• Conditions: Hemispatial Neglect
• Interventions: Device: Transcranial Magnetic Stimulation (TMS); Device: sham Transcranial Magnetic Stimulation (TMS); Device: Transcranial Alternating Current Stimulation (tACS); Device: sham Transcranial Alternating Current Stimulation (tACS)

• Registration Number: NCT03090711
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

Brain functions are supported by multiple cell types, including neuronal and non-neuronal cells that are connected into complex networks. When the connectivity between those cells is altered or disrupted, the functioning of the brain is impaired. In stroke, the interruption of blood supply to the neural circuits results in connectivity damage and permanent disabilities. Experimental evidence suggests that some types of brain state, including sleep, can protect brain tissue from stroke and "repair" the damaged circuits. This project will investigate the neuronal mechanism underlying the protective effect of sleep on brain connectivity and network activity. To this end, the investigators will use a collection of state-of-the-art technologies including high-density electroencephalography (hd-EEG), transcranial magnetic stimulation (TMS) and transcranial alternating current stimulation (tACS). Perspectives include a better understanding of the causes and consequences of the perturbed electrical activity of the brain during sleep in stroke patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-27
• Study Start: 2017-08-02
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Informed consent as documented by signature
• Age between 18 and 80 years
• First-ever right-sided stroke
• Normal or corrected to normal vision
• Demonstration of left hemispatial neglect (after a right-hemispheric brain lesion) found in a comprehensive neuropsychological test battery and clinical assessment
• At least 3 weeks post-stroke

Exclusion Criteria

• Concomitant neurodegenerative diseases
• Psychiatric diseases
• Decompressive craniectomy
• History of documented sleep disorders in the medical record (e.g. insomnia, hypersomnia, rem-sleep behaviour disorder)
• Epileptic seizures
• Implanted medical devices (e.g.: pacemakers, cochlear implants, implanted neurostimulators)
• Presence of metal in the region of the head (excluding fixed dental implants such as tooth fillings or fixed dental braces)
• Medication with drugs possibly lowering the seizure threshold
• Alcohol or drug abuse
• Inability to follow the procedures of the study
• For female patients: in order to participate in the study, female patients in reproductive age need to take a pregnancy test (a standard urine pregnancy test will be provided).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMS	Transcranial Magnetic Stimulation (TMS)	Real transcranial magnetic stimulation (TMS).
sham TMS	sham Transcranial Magnetic Stimulation (TMS)	Sham transcranial magnetic stimulation (TMS) as a comparison.
TMS and tACS	Transcranial Magnetic Stimulation (TMS)	Real transcranial magnetic stimulation (TMS) and real transcranial alternating current stimulation (tACS).
TMS and tACS	Transcranial Alternating Current Stimulation (tACS)	Real transcranial magnetic stimulation (TMS) and real transcranial alternating current stimulation (tACS).
TMS and sham tACS	sham Transcranial Alternating Current Stimulation (tACS)	Real transcranial magnetic stimulation (TMS) and sham transcranial alternating current stimulation (tACS) as a comparison.
TMS and sham tACS	Transcranial Magnetic Stimulation (TMS)	Real transcranial magnetic stimulation (TMS) and sham transcranial alternating current stimulation (tACS) as a comparison.

Primary Outcome Measures

Name	Time	Method
Change from baseline in visual exploration and sleep parameters and the effect of cTBS	Day 3	Relationship of visual exploration (mean cumulative fixation duration) to sleep parameters (slow wave activity and spindles) from the baseline to post-cTBS sleep.
Change from baseline in the effect of tACS on visual exploration	Day 2	Group comparison of visual exploration task (mean cumulative fixation duration) between real and sham tACS.

Secondary Outcome Measures

Name	Time	Method
The effect of tACS on sleep	Day 1 to 2	Change in sleep architecture (REM and NREM sleep) between tACS and sham stimulation.
The effect of cTBS on sleep	Day 1 to 3	Relationship between baseline sleep parameters (slow wave activity and spindles) and effectiveness of cTBS.

Trial Locations

Locations (1)

Department of Neurology, Inselspital, Bern University Hospital; 🇨🇭 Berne, Switzerland