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

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ClinicalTrials.gov Identifier: NCT03090711
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Hemispatial Neglect Device: Transcranial Magnetic Stimulation (TMS) Device: Transcranial Alternating Current Stimulation (tACS) Device: sham Transcranial Magnetic Stimulation (TMS) Device: sham Transcranial Alternating Current Stimulation (tACS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Sleep as a Model to Understand and Manipulate Cortical Activity in Order to Promote Neuroplasticity and Functional Recovery After Stroke
Actual Study Start Date : August 2, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: TMS
Real transcranial magnetic stimulation (TMS).
Device: Transcranial Magnetic Stimulation (TMS)
The investigators recently showed that the repeated application of the so-called continuous theta burst protocol (cTBS) over the contralesional hemisphere resulted in a long-standing improvement of visual hemineglect (Cazzoli et al., 2012). The cTBS protocol was developed by Huang et al. (Huang et al., 2005) and modified by the investigators' group (Nyffeler et al., 2006). TBS protocol consists of a burst of 3 pulses at a frequency of 30 Hz, repeated at 6 Hz. One continuous train includes 801 pulses, the duration of one cTBS train is 44 seconds.

Sham Comparator: sham TMS
Sham transcranial magnetic stimulation (TMS) as a comparison.
Device: sham Transcranial Magnetic Stimulation (TMS)
Sham coil will be used to exclude possible nonspecific effects of the TMS. The sham coil is shielded i.e., the magnetic field output is weakened and therefore insufficiently powerful to stimulate the cortex.

Experimental: TMS and tACS
Real transcranial magnetic stimulation (TMS) and real transcranial alternating current stimulation (tACS).
Device: Transcranial Magnetic Stimulation (TMS)
The investigators recently showed that the repeated application of the so-called continuous theta burst protocol (cTBS) over the contralesional hemisphere resulted in a long-standing improvement of visual hemineglect (Cazzoli et al., 2012). The cTBS protocol was developed by Huang et al. (Huang et al., 2005) and modified by the investigators' group (Nyffeler et al., 2006). TBS protocol consists of a burst of 3 pulses at a frequency of 30 Hz, repeated at 6 Hz. One continuous train includes 801 pulses, the duration of one cTBS train is 44 seconds.

Device: Transcranial Alternating Current Stimulation (tACS)
TACS stimulation involves two electrodes placed on either side of the desired site of cortical stimulation. The mode of stimulation used in this experiment is identical to previous studies using tACS in sleep ( Marshall et al., 2006; Prehn-Kristensen et al., 2014 ). Stimulation follows a sinusoidal pattern from 0 to 260 μA. This pattern is delivered at 0.75 Hz and is repeated for 225 cycles; a total of 5 minutes of stimulation. This 5 minute pattern is again repeated 5 times, with a minute of no stimulation between each; thus for a total of 30 minutes.

Sham Comparator: TMS and sham tACS
Real transcranial magnetic stimulation (TMS) and sham transcranial alternating current stimulation (tACS) as a comparison.
Device: Transcranial Magnetic Stimulation (TMS)
The investigators recently showed that the repeated application of the so-called continuous theta burst protocol (cTBS) over the contralesional hemisphere resulted in a long-standing improvement of visual hemineglect (Cazzoli et al., 2012). The cTBS protocol was developed by Huang et al. (Huang et al., 2005) and modified by the investigators' group (Nyffeler et al., 2006). TBS protocol consists of a burst of 3 pulses at a frequency of 30 Hz, repeated at 6 Hz. One continuous train includes 801 pulses, the duration of one cTBS train is 44 seconds.

Device: sham Transcranial Alternating Current Stimulation (tACS)
Sham stimulation will be used to exclude possible nonspecific effects of the tACS. Sham tACS stimulation will involve actual stimulation for the first 30 seconds of the ramp-up period (stimulation power is gradually increased until its final level), and then immediately gradually decreased until zero (without the intermediate 4 minutes of actual stimulation). This procedure will be repeated 5 times every 6 minutes and shall induce similar cutaneous sensations as real stimulation.




Primary Outcome Measures :
  1. Change from baseline in visual exploration and sleep parameters and the effect of cTBS [ Time Frame: 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.

  2. Change from baseline in the effect of tACS on visual exploration [ Time Frame: Day 2 ]
    Group comparison of visual exploration task (mean cumulative fixation duration) between real and sham tACS.


Secondary Outcome Measures :
  1. The effect of cTBS on sleep [ Time Frame: Day 1 to 3 ]
    Relationship between baseline sleep parameters (slow wave activity and spindles) and effectiveness of cTBS.

  2. The effect of tACS on sleep [ Time Frame: Day 1 to 2 ]
    Change in sleep architecture (REM and NREM sleep) between tACS and sham stimulation.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090711


Contacts
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Contact: Claudio L. Bassetti, Prof. Dr. med. 31 63 2 30 66 ext +41 Claudio.Bassetti@insel.ch
Contact: René M. Müri, Prof. Dr. med. 31 632 30 81 ext +41 rene.mueri@insel.ch

Locations
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Switzerland
Department of Neurology, Inselspital, Bern University Hospital Recruiting
Berne, Switzerland, 3010
Contact: Claudio L. Bassetti, Prof. Dr. med.    31 63 2 30 66 ext +41    claudio.bassetti@insel.ch   
Contact: René M. Müri, Prof. Dr. med.    31 632 30 81 ext +41    rene.mueri@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Claudio L. Bassetti, Prof. Dr. med. Department of Neurology, Inselspital, Bern University Hospital

Publications of Results:
Other Publications:
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03090711     History of Changes
Other Study ID Numbers: 2016-01387
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms