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

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Hemispatial Neglect

Treatments: Device: sham Transcranial Alternating Current Stimulation (tACS); Device: Transcranial Alternating Current Stimulation (tACS); Device: Transcranial Magnetic Stimulation (TMS); Device: sham Transcranial Magnetic Stimulation (TMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03090711

2016-01387

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 4 patient groups

TMS

Experimental group

Description:

Real transcranial magnetic stimulation (TMS).

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

sham TMS

Sham Comparator group

Description:

Sham transcranial magnetic stimulation (TMS) as a comparison.

Treatment:

Device: sham Transcranial Magnetic Stimulation (TMS)

TMS and tACS

Experimental group

Description:

Real transcranial magnetic stimulation (TMS) and real transcranial alternating current stimulation (tACS).

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

Device: Transcranial Alternating Current Stimulation (tACS)

TMS and sham tACS

Sham Comparator group

Description:

Real transcranial magnetic stimulation (TMS) and sham transcranial alternating current stimulation (tACS) as a comparison.

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

Device: sham Transcranial Alternating Current Stimulation (tACS)