Aphasia Following Cerebral InfarctionPhase 2NCT03305614
TDCS and Aphasia Therapy in the Chronic Phase After Stroke
A Phase 2 study testing tDCS and Aphasia therapy in people with Aphasia Following Cerebral Infarction and Aphasia Following Nontraumatic Intracerebral Hemorrhage, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in patients in the chronic phase after stroke. Half of the participants will receive aphasia therapy and tDCS, the other half will receive aphasia therapy and sham-tDCS. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aphasia Following Cerebral Infarction, Aphasia Following Nontraumatic Intracerebral Hemorrhage
- What is being tested?
- tDCS and Aphasia therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Nov 2017to 18 Apr 2018
- Phase
- Phase 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with mild to moderate aphasia (Token Test Score between 7 and 40) after a first left hemispheric ischemic or hemorrhagic stroke
- Age 18 - 85 years
- Being right-handed (> +8 on the questionnaire for handedness, Van Strien)
- Mothertongue: Dutch
- Imaging (CT or MRI) prior to inclusion (in patient file), standard of care in the acute phase
- Signed Informed Consent (attachment 1)
Who cannot join
- History of other diseases of the central nervous system, psychological disorders and (developmental) speech and or language disorders
- Serious non-linguistic, cognitive disorders (as documented in the patients' medical history and inquired in the anamneses)
- Prior brain surgery
- Excessive use of alcohol or drugs
- New neurological symptoms between the acute stage and inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Neuromodulatory Effect of Combined Transcranial Direct Current Stimulation with Intensive Aphasia Therapy in the Chronic Phase After Stroke
This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in patients in the chronic phase after stroke. Half of the participants will receive aphasia therapy and tDCS, the other half will receive aphasia therapy and sham-tDCS.
Read the detailed description
Aphasia is present in about one third of all stroke patients in the chronic phase. The first few months after stroke, considerable spontaneous recovery is initiated, including neuronal plasticity and reorganization processes. Language recovery in aphasic stroke patients involves reorganization of brain functions. Longitudinal fMRI studies reveal that the right hemisphere shows increased activity at different times in the recovery process, but in the long-term is correlated with poorer performance. Left re-lateralization, if possible, seems to be the most effective in restoring language function. For a large subgroup of patients, aphasia therapy is not sufficient to resolve language deficits and not all patients are capable to endure intensive aphasia therapy. Therefore, non-invasive techniques (NIBS) such as transcranial direct current stimulation (tDCS) are currently explored as an add-on treatment to improve or accelerate therapy outcomes. tDCS is a painless and safe stimulation tool that modulates cortical excitability through weak polarizing currents (1 mA - 2 mA) between two electrodes. These weak currents are thought to induce a subthreshold shift of resting membrane potentials towards depolarization or hyperpolarization. The effects of stimulation depend on the polarity of the applied current relative to the axonal orientation. It has been found that tDCS not only triggers immediate aftereffects, but also long-lasting effects that persist beyond the stimulation time, even for up to 12 months. It was suggested that long-term potentiation (LTP) and long-term depression (LTD) might be responsible for these long-term effects, however the precise physiologic mechanisms of action are not yet fully understood.
- Conditions
- Aphasia Following Cerebral Infarction, Aphasia Following Nontraumatic Intracerebral Hemorrhage
- Being tested
- tDCS, Aphasia therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSProcedure or surgery
C-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA or sham-tDCS at an intensity of 0mA
Aphasia therapyProcedure or surgery
Based on linguistic tests, individualized aphasia therapy will be provided
| Study group | Role | What they receive |
|---|---|---|
| Aphasia therapy and tDCS | Active comparator | combined tDCS and aphasia therapy and the effect of conventional intensive aphasia Receives: Procedure: tDCS; Procedure: Aphasia therapy |
| Aphasia therapy and sham-tDCS | Sham comparator | computer-based intensive aphasia therapy as measured by specific linguistic tests Receives: Procedure: Aphasia therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in naming performance assessed with the Boston Naming Test
Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 +/- 1 month following treatment
Measured: baseline, 3 weeks, 3 +/-1 month
Secondary outcomes (4)
Change in tolerability assessed with a Visual analogue scale
A Visual analogue scale will asses tolerability before and immediately after each session
Measured: baseline, 2 hour (each session)
Change in spontaneous speech assessed with a Semi-standardized interview of the AAT
A Semi-standardized interview of the AAT will assess functional communication at baseline, immediately after therapy, and at 3 +/- 1 month follow-up
Measured: baseline, 3 weeks, 3 +/- 1 month
Change in ERPs
Evoked potentials will be measured at baseline, immediately after treatment and after 3 +/- 1 month
Measured: baseline, 3 weeks, 3 +/- 1 month
Change in quality of life assessed with the SAQOL-39-NL
The SAQOL-39-NL will assess the quality of life at baseline, immediately after treatment and at 3 +/-1 month follow-up
Measured: baseline, 3 weeks, 3+/- 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start24 Nov 2017
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Why it stopped: Reason unknown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia Following Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veerle De Herdt, Prof. Dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305614
- Sponsor's protocol ID
- BC-136-TVE
- Status last verified
- Sep 2024
- First submitted
- 28 Sep 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuromodulatory Effect of Combined Transcranial Direct Current Stimulation with Intensive Aphasia Therapy in the Chronic Phase After Stroke
- ClinicalTrials.gov ID
- NCT03305614
- Acronym / sponsor ID
- BC-136-TVE
- Conditions
- Aphasia Following Cerebral Infarction, Aphasia Following Nontraumatic Intracerebral Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reason unknown
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 24 Nov 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 10 Oct 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.
This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in patients in the chronic phase after stroke. Half of the participants will receive aphasia therapy and tDCS, the other half will receive aphasia therapy and sham-tDCS.
Detailed description
Aphasia is present in about one third of all stroke patients in the chronic phase. The first few months after stroke, considerable spontaneous recovery is initiated, including neuronal plasticity and reorganization processes. Language recovery in aphasic stroke patients involves reorganization of brain functions. Longitudinal fMRI studies reveal that the right hemisphere shows increased activity at different times in the recovery process, but in the long-term is correlated with poorer performance. Left re-lateralization, if possible, seems to be the most effective in restoring language function. For a large subgroup of patients, aphasia therapy is not sufficient to resolve language deficits and not all patients are capable to endure intensive aphasia therapy. Therefore, non-invasive techniques (NIBS) such as transcranial direct current stimulation (tDCS) are currently explored as an add-on treatment to improve or accelerate therapy outcomes. tDCS is a painless and safe stimulation tool that modulates cortical excitability through weak polarizing currents (1 mA - 2 mA) between two electrodes. These weak currents are thought to induce a subthreshold shift of resting membrane potentials towards depolarization or hyperpolarization. The effects of stimulation depend on the polarity of the applied current relative to the axonal orientation. It has been found that tDCS not only triggers immediate aftereffects, but also long-lasting effects that persist beyond the stimulation time, even for up to 12 months. It was suggested that long-term potentiation (LTP) and long-term depression (LTD) might be responsible for these long-term effects, however the precise physiologic mechanisms of action are not yet fully understood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aphasia therapy and tDCS | Active comparator | Procedure: tDCS, Procedure: Aphasia therapycombined tDCS and aphasia therapy and the effect of conventional intensive aphasia |
| Aphasia therapy and sham-tDCS | Sham comparator | Procedure: Aphasia therapycomputer-based intensive aphasia therapy as measured by specific linguistic tests |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with mild to moderate aphasia (Token Test Score between 7 and 40) after a first left hemispheric ischemic or hemorrhagic stroke
- Age 18 - 85 years
- Being right-handed (> +8 on the questionnaire for handedness, Van Strien)
- Mothertongue: Dutch
- Imaging (CT or MRI) prior to inclusion (in patient file), standard of care in the acute phase
Key exclusion criteria (5 listed)
- History of other diseases of the central nervous system, psychological disorders and (developmental) speech and or language disorders
- Serious non-linguistic, cognitive disorders (as documented in the patients' medical history and inquired in the anamneses)
- Prior brain surgery
- Excessive use of alcohol or drugs
- New neurological symptoms between the acute stage and inclusion
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 |
|---|---|---|
| tDCSC-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA or sham-tDCS at an intensity of 0mA | Procedure or surgery | Aphasia therapy and tDCS |
| Aphasia therapyBased on linguistic tests, individualized aphasia therapy will be provided | Procedure or surgery | Aphasia therapy and sham-tDCS, Aphasia therapy and tDCS |
Primary outcome
Change in naming performance assessed with the Boston Naming Test
Time frame: baseline, 3 weeks, 3 +/-1 month
Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 +/- 1 month following treatment
4 secondary outcomes
Change in tolerability assessed with a Visual analogue scale
Time frame: baseline, 2 hour (each session)
Change in spontaneous speech assessed with a Semi-standardized interview of the AAT
Time frame: baseline, 3 weeks, 3 +/- 1 month
Change in ERPs
Time frame: baseline, 3 weeks, 3 +/- 1 month
Change in quality of life assessed with the SAQOL-39-NL
Time frame: baseline, 3 weeks, 3+/- 1 month
Results and safety
The study was stopped early (reason given: Reason unknown). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Aphasia Following Cerebral Infarction, Stroke Ischemic
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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.
Veerle De Herdt, Prof. Dr. principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tDCS and Aphasia therapy in people with Aphasia Following Cerebral Infarction and Aphasia Following Nontraumatic Intracerebral Hemorrhage, run by University Hospital, Ghent at 1 site in Belgium.
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 5 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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 Belgium. 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 phase mean?
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 was stopped early (reason given: Reason unknown). Results are not available in the source record.
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 in naming performance assessed with the Boston Naming Test (time frame: baseline, 3 weeks, 3 +/-1 month). 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 19 Sep 2024.