Hemispatial NeglectSSSNCT03090711
Sleep as a Model to Understand and Manipulate Cortical Activity in Order to Promote Functional Recovery After Stroke
A study testing Transcranial Magnetic Stimulation (TMS) and Transcranial Alternating Current Stimulation (tACS) in people with Hemispatial Neglect, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemispatial Neglect
- What is being tested?
- Transcranial Magnetic Stimulation (TMS) and Transcranial Alternating Current Stimulation (tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Aug 2017to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neurology, Inselspital, Bern University Hospital
Bern, 3010
About this study
Official title: Sleep as a Model to Understand and Manipulate Cortical Activity in Order to Promote Neuroplasticity and Functional Recovery After Stroke
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.
- Conditions
- Hemispatial Neglect
- Being tested
- Transcranial Magnetic Stimulation (TMS), Transcranial Alternating Current Stimulation (tACS), sham Transcranial Magnetic Stimulation (TMS), sham Transcranial Alternating Current Stimulation (tACS)
- Medical subject headings
- Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Device
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.
Transcranial Alternating Current Stimulation (tACS)Device
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 Transcranial Magnetic Stimulation (TMS)Device
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.
sham Transcranial Alternating Current Stimulation (tACS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| TMS | Experimental | Real transcranial magnetic stimulation (TMS). Receives: Device: Transcranial Magnetic Stimulation (TMS) |
| sham TMS | Sham comparator | Sham transcranial magnetic stimulation (TMS) as a comparison. Receives: Device: sham Transcranial Magnetic Stimulation (TMS) |
| TMS and tACS | Experimental | Real transcranial magnetic stimulation (TMS) and real transcranial alternating current stimulation (tACS). Receives: Device: Transcranial Magnetic Stimulation (TMS); Device: Transcranial Alternating Current Stimulation (tACS) |
| TMS and sham tACS | Sham comparator | Real transcranial magnetic stimulation (TMS) and sham transcranial alternating current stimulation (tACS) as a comparison. Receives: Device: Transcranial Magnetic Stimulation (TMS); Device: sham Transcranial Alternating Current Stimulation (tACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 3
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.
Measured: Day 2
Secondary outcomes (2)
The effect of cTBS on sleep
Relationship between baseline sleep parameters (slow wave activity and spindles) and effectiveness of cTBS.
Measured: Day 1 to 3
The effect of tACS on sleep
Change in sleep architecture (REM and NREM sleep) between tACS and sham stimulation.
Measured: Day 1 to 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start2 Aug 2017
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hemispatial NeglectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio L. Bassetti, Prof. Dr. med., Principal investigator, Department of Neurology, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090711
- Sponsor's protocol ID
- 2016-01387
- Other IDs
- 2016
- Acronym
- SSS
- Status last verified
- Apr 2021
- First submitted
- 9 Mar 2017
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15664172Nyffeler 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.
PubMed 17049743Cazzoli 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.
PubMed 22831781Marshall 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.
PubMed 17086200
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep as a Model to Understand and Manipulate Cortical Activity in Order to Promote Neuroplasticity and Functional Recovery After Stroke
- ClinicalTrials.gov ID
- NCT03090711
- Acronym / sponsor ID
- SSS / 2016-01387
- Conditions
- Hemispatial Neglect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TMS | Experimental | Device: Transcranial Magnetic Stimulation (TMS)Real transcranial magnetic stimulation (TMS). |
| sham TMS | Sham comparator | Device: sham Transcranial Magnetic Stimulation (TMS)Sham transcranial magnetic stimulation (TMS) as a comparison. |
| TMS and tACS | Experimental | Device: Transcranial Magnetic Stimulation (TMS), Device: Transcranial Alternating Current Stimulation (tACS)Real transcranial magnetic stimulation (TMS) and real transcranial alternating current stimulation (tACS). |
| TMS and sham tACS | Sham comparator | Device: Transcranial Magnetic Stimulation (TMS), Device: sham Transcranial Alternating Current Stimulation (tACS)Real transcranial magnetic stimulation (TMS) and sham transcranial alternating current stimulation (tACS) as a comparison. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | TMS, TMS and sham tACS, TMS and tACS |
| 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. | Device | TMS and tACS |
| 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. | Device | sham TMS |
| 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. | Device | TMS and sham tACS |
Primary outcome
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.
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.
2 secondary outcomes
The effect of cTBS on sleep
Time frame: Day 1 to 3
The effect of tACS on sleep
Time frame: Day 1 to 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Background: PubMed 15664172Huang 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.
- Background: PubMed 17049743Nyffeler 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 publication: PubMed 22831781Cazzoli 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 publication: PubMed 17086200Marshall 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio L. Bassetti, Prof. Dr. med. principal investigator
Department of Neurology, Inselspital, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) and Transcranial Alternating Current Stimulation (tACS) in people with Hemispatial Neglect, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in visual exploration and sleep parameters and the effect of cTBS (time frame: Day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03090711, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.