HemianopiaPhase 1/2NCT02703870
Combined tDCS and Vision Restoration Training in Post-acute Stroke: an Exploratory Efficacy and Safety Study
A Phase 1/2 study testing verum tDCS and VRT in people with Hemianopia and Stroke, run by University of Magdeburg at 2 sites in 2 countries.
Trial summary
The purpose of this Study is to determine whether non-invasive transcranial direct current stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual Cortex. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemianopia, Stroke
- What is being tested?
- verum tDCS and VRT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2013to Dec 2015
- Phase
- Phase 1/2
- 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
- Posterior Cerebral Artery Stroke
- Visual Field Defect
- Lesion age 4 weeks up to 6 month max.
Who cannot join
- Electrical Implants
- Metal artefacts in head
- Epilepsy
- Visual Neglect
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Inst. f. Medical Psychology, Univ. of Magdeburg
Magdeburg, 39120
About this study
The purpose of this Study is to determine whether non-invasive transcranial direct current stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual Cortex.
Read the detailed description
Visual field defects after posterior cerebral artery stroke can be improved by vision restoration training (VRT), but when combined with transcranial direct current stimulation (tDCS) which alters brain excitability, vision restoration can be potentiated in the chronic stage. Because it is possible that such therapy may be more effective during the early recovery phase after the stroke and can reach patients during the rehabilitation phase, investigators wished to explore the applicability, efficacy and safety of early intervention with a combined tDCS/VRT treatment.
19 post-acute stroke homonymous hemianopia patients were randomly assigned to either 10 sessions of combined rea-tDCS (2mA, 10 daily sessions of 15-20 min) and VRT, or sham-tDCS and VRT. The primary outcome criterion was the pre-post change in perimetric detection thresholds. Secondary outcome is neurophysiological changes in EEG measures (VEP, Connectivity, Spectral Power, ...)
- Conditions
- Hemianopia, Stroke
- Being tested
- verum tDCS, sham tDCS, VRT
- Medical subject headings
- Hemianopsia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verum tDCSDevice
real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes
sham tDCSDevice
sham transcranial direct current stimulation, 10 sessions, for 20 minutes
VRTBehavioural
Vision restoration training, 10 sessions, 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Verum tDCS | Active comparator | Verum group receiving complete treatment of tDCS Receives: Device: verum tDCS; Behavioral: VRT |
| sham tDCS | Sham comparator | Sham group receiving sham tDCS Receives: Device: sham tDCS; Behavioral: VRT |
| real VRT | Active comparator | Real Vision Restoration Training Receives: Device: verum tDCS; Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention and follow up
Measured: 14-20 days post treatment, 3 months follow up
Secondary outcomes (5)
Change in power spectra (Volts-squared per Hz (V^2/Hz) from baseline to post-intervention and follow up
power spectra (Volts-squared per Hz (V^2/Hz)
Measured: 14-20 days post treatment, 3 months follow up
Change in VEP latencies (ms) from baseline to post-intervention and follow up
VEP latencies (ms)
Measured: 14-20 days post treatment, 3 months follow up
Change in VEP amplitudes (µV) from baseline to post-intervention and follow up
VEP amplitudes (µV)
Measured: 14-20 days post treatment, 3 months follow up
Change in network coherence from baseline to post-intervention and follow up
network coherence correlations
Measured: 14-20 days post treatment, 3 months follow up
Number of participants with treatment-related adverse events assessed by a questionnaire
questionnaire recording adverse effects
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemianopiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Collaborators
- Neurologisches Therapiezentrum Gmundnerberg
- Responsible party
- Principal investigator, Bernhard A. Sabel, University of Magdeburg
- Investigators
- Bernhard A Sabel, Prof. Dr., Study director, Institute of Medical Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703870
- Sponsor's protocol ID
- CES_NTG_1
- Status last verified
- Mar 2016
- First submitted
- 18 Sep 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined tDCS and Vision Restoration Training in Post-acute Stroke: an Exploratory Efficacy and Safety Study
- ClinicalTrials.gov ID
- NCT02703870
- Acronym / sponsor ID
- CES_NTG_1
- Conditions
- Hemianopia, Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Collaborators
- Neurologisches Therapiezentrum Gmundnerberg
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Mar 2016 (estimated)
- 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.
The purpose of this Study is to determine whether non-invasive transcranial direct current stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual Cortex.
Detailed description
Visual field defects after posterior cerebral artery stroke can be improved by vision restoration training (VRT), but when combined with transcranial direct current stimulation (tDCS) which alters brain excitability, vision restoration can be potentiated in the chronic stage. Because it is possible that such therapy may be more effective during the early recovery phase after the stroke and can reach patients during the rehabilitation phase, investigators wished to explore the applicability, efficacy and safety of early intervention with a combined tDCS/VRT treatment.
19 post-acute stroke homonymous hemianopia patients were randomly assigned to either 10 sessions of combined rea-tDCS (2mA, 10 daily sessions of 15-20 min) and VRT, or sham-tDCS and VRT. The primary outcome criterion was the pre-post change in perimetric detection thresholds. Secondary outcome is neurophysiological changes in EEG measures (VEP, Connectivity, Spectral Power, ...)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Verum tDCS | Active comparator | Device: verum tDCS, Behavioral: VRTVerum group receiving complete treatment of tDCS |
| sham tDCS | Sham comparator | Device: sham tDCS, Behavioral: VRTSham group receiving sham tDCS |
| real VRT | Active comparator | Device: verum tDCS, Device: sham tDCSReal Vision Restoration Training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Posterior Cerebral Artery Stroke
- Visual Field Defect
- Lesion age 4 weeks up to 6 month max.
Key exclusion criteria (4 listed)
- Electrical Implants
- Metal artefacts in head
- Epilepsy
- Visual Neglect
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 |
|---|---|---|
| verum tDCSreal transcranial direct current stimulation,10 sessions, 2mA for 20 minutes | Device | Verum tDCS, real VRT |
| sham tDCSsham transcranial direct current stimulation, 10 sessions, for 20 minutes | Device | real VRT, sham tDCS |
| VRTVision restoration training, 10 sessions, 20 minutes | Behavioural | Verum tDCS, sham tDCS |
Primary outcome
Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention and follow up
Time frame: 14-20 days post treatment, 3 months follow up
5 secondary outcomes
Change in power spectra (Volts-squared per Hz (V^2/Hz) from baseline to post-intervention and follow up
Time frame: 14-20 days post treatment, 3 months follow up
Change in VEP latencies (ms) from baseline to post-intervention and follow up
Time frame: 14-20 days post treatment, 3 months follow up
Change in VEP amplitudes (µV) from baseline to post-intervention and follow up
Time frame: 14-20 days post treatment, 3 months follow up
Change in network coherence from baseline to post-intervention and follow up
Time frame: 14-20 days post treatment, 3 months follow up
Number of participants with treatment-related adverse events assessed by a questionnaire
Time frame: up to 4 months
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 9 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Hemianopia
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Not yet recruiting
Multisensory Rehabilitation of Vision Loss After Cortical Damage
Cortical Blindness
Recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Not yet recruitingObservational study
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
Homonymous Hemianopia, Stroke
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.
Bernhard A Sabel, Prof. Dr. study director
Institute of Medical Psychology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing verum tDCS and VRT in people with Hemianopia and Stroke, run by University of Magdeburg at 2 sites in 2 countries.
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 3 inclusion and 4 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 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 of mean sensitivity (in dB) detection threshold from baseline to post-intervention and follow up (time frame: 14-20 days post treatment, 3 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2016.