Clinical trial NCT03090711: Sleep as a Model to Understand and Manipulate Cortical Activity in Order to Promote Functional Recovery After Stroke
Official title: Sleep as a Model to Understand and Manipulate Cortical Activity in Order to Promote Neuroplasticity and Functional Recovery After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemispatial Neglect
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline in visual exploration and sleep parameters and the effect of cTBS
timeFrame: Day 3
measure: Change from baseline in the effect of tACS on visual exploration
timeFrame: Day 2
Secondary outcomes:
measure: The effect of cTBS on sleep
timeFrame: Day 1 to 3
measure: The effect of tACS on sleep
timeFrame: Day 1 to 2
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Department of Neurology, Inselspital, Bern University Hospital
Study officials:
affiliation: Department of Neurology, Inselspital, Bern University Hospital
name: Claudio L. Bassetti, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.
citation: Nyffeler T, Wurtz P, Luscher HR, Hess CW, Senn W, Pflugshaupt T, von Wartburg R, Luthi M, Muri RM. Repetitive TMS over the human oculomotor cortex: comparison of 1-Hz and theta burst stimulation. Neurosci Lett. 2006 Nov 27;409(1):57-60. doi: 10.1016/j.neulet.2006.09.011. Epub 2006 Oct 17.
citation: Cazzoli D, Muri RM, Schumacher R, von Arx S, Chaves S, Gutbrod K, Bohlhalter S, Bauer D, Vanbellingen T, Bertschi M, Kipfer S, Rosenthal CR, Kennard C, Bassetti CL, Nyffeler T. Theta burst stimulation reduces disability during the activities of daily living in spatial neglect. Brain. 2012 Nov;135(Pt 11):3426-39. doi: 10.1093/brain/aws182. Epub 2012 Jul 24.
citation: Marshall L, Helgadottir H, Molle M, Born J. Boosting slow oscillations during sleep potentiates memory. Nature. 2006 Nov 30;444(7119):610-3. doi: 10.1038/nature05278. Epub 2006 Nov 5.