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

Primary Purpose

Hemispatial Neglect

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
Transcranial Alternating Current Stimulation (tACS)
sham Transcranial Magnetic Stimulation (TMS)
sham Transcranial Alternating Current Stimulation (tACS)
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hemispatial Neglect

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Department of Neurology, Inselspital, Bern University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

TMS

sham TMS

TMS and tACS

TMS and sham tACS

Arm Description

Real transcranial magnetic stimulation (TMS).

Sham transcranial magnetic stimulation (TMS) as a comparison.

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

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

Outcomes

Primary Outcome Measures

Change from baseline in visual exploration and sleep parameters and the effect of cTBS
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
Group comparison of visual exploration task (mean cumulative fixation duration) between real and sham tACS.

Secondary Outcome Measures

The effect of cTBS on sleep
Relationship between baseline sleep parameters (slow wave activity and spindles) and effectiveness of cTBS.
The effect of tACS on sleep
Change in sleep architecture (REM and NREM sleep) between tACS and sham stimulation.

Full Information

First Posted
March 9, 2017
Last Updated
April 30, 2021
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03090711
Brief Title
Sleep as a Model to Understand and Manipulate Cortical Activity in Order to Promote Functional Recovery After Stroke
Acronym
SSS
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemispatial Neglect

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMS
Arm Type
Experimental
Arm Description
Real transcranial magnetic stimulation (TMS).
Arm Title
sham TMS
Arm Type
Sham Comparator
Arm Description
Sham transcranial magnetic stimulation (TMS) as a comparison.
Arm Title
TMS and tACS
Arm Type
Experimental
Arm Description
Real transcranial magnetic stimulation (TMS) and real transcranial alternating current stimulation (tACS).
Arm Title
TMS and sham tACS
Arm Type
Sham Comparator
Arm Description
Real transcranial magnetic stimulation (TMS) and sham transcranial alternating current stimulation (tACS) as a comparison.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Alternating Current Stimulation (tACS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham Transcranial Magnetic Stimulation (TMS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham Transcranial Alternating Current Stimulation (tACS)
Intervention Description
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 Measure Information:
Title
Change from baseline in visual exploration and sleep parameters and the effect of cTBS
Description
Relationship of visual exploration (mean cumulative fixation duration) to sleep parameters (slow wave activity and spindles) from the baseline to post-cTBS sleep.
Time Frame
Day 3
Title
Change from baseline in the effect of tACS on visual exploration
Description
Group comparison of visual exploration task (mean cumulative fixation duration) between real and sham tACS.
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
The effect of cTBS on sleep
Description
Relationship between baseline sleep parameters (slow wave activity and spindles) and effectiveness of cTBS.
Time Frame
Day 1 to 3
Title
The effect of tACS on sleep
Description
Change in sleep architecture (REM and NREM sleep) between tACS and sham stimulation.
Time Frame
Day 1 to 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio L. Bassetti, Prof. Dr. med.
Organizational Affiliation
Department of Neurology, Inselspital, Bern University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Inselspital, Bern University Hospital
City
Berne
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15664172
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.
Results Reference
background
PubMed Identifier
17049743
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.
Results Reference
background
PubMed Identifier
22831781
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.
Results Reference
result
PubMed Identifier
17086200
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.
Results Reference
result

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

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