Aphasia Following Cerebral InfarctionNCT03297450
TDCS and Aphasia Therapy in the Acute Phase After Stroke
A study testing tDCS and Aphasia therapy in people with Aphasia Following Cerebral Infarction, 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 acute stage 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
- What is being tested?
- tDCS and Aphasia therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Oct 2017to 30 Mar 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with mild-moderate aphasia (Token Test Score between 7 and 40)
- Inclusion in the first few days after stroke (acute phase)
- Age 18 - 85 years
- Being right-handed
- Mothertongue: Dutch
- Able to undergo functional and specific linguistic testing and therapy in the acute phase following stroke
- Imaging (CT or MRI) prior to inclusion (standard of care)
- Signed Informed Consent
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 anamneses)
- Prior brain surgery
- Excessive use of alcohol or drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Neuromodulatory Effect of Combined Transcranial Direct Current Stimulation (tDCS) with Aphasia Therapy in the Acute Phase After Ischemic Stroke
This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in patients in the acute stage 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 acute 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
- Being tested
- tDCS, Aphasia therapy, Sham-tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
C-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA
Aphasia therapyBehavioural
Based on linguistic tests, individualized aphasia therapy will be provided
Sham-tDCSDevice
tDCS during the first 20 minutes of aphasia therapy at an intensity of 0mA (Sham)
| Study group | Role | What they receive |
|---|---|---|
| Aphasia therapy and tDCS | Active comparator | Not described Receives: Device: tDCS; Behavioral: Aphasia therapy |
| Aphasia therapy and sham-tDCS | Sham comparator | Not described Receives: Behavioral: Aphasia therapy; Device: Sham-tDCS |
| Standard of care and sham-tDCS | Sham comparator | Not described Receives: Device: Sham-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in naming performance
Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 and 6 months
Measured: baseline, 1 week, 3 months, 6 months
Change in Vital Parameters
Blood pressure and heart rate will be measured before and after each session of treatment
Measured: baseline, 1 hour (each session)
Secondary outcomes (3)
Change in tolerability (Visual analogue scale)
A Visual analogue scale will assess tolerability before and immediately after each session
Measured: baseline, 1 hour (each session)
Change in Spontaneous Speech
A Semi-standardized interview of the AAT will assess functional communication at baseline, immediately after therapy, and at 3 and 6 months
Measured: baseline, 1 week, 3 months, 6 months
Change in ERPs
Evoked potentials will be measured at baseline, immediately after treatment and after 3 and 6 months
Measured: baseline, 1 week, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start2 Oct 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Why it stopped: Difficult patient recruitment
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- aphasia therapy (45 minutes) in combination with (sham or real) tDCS (20 minutes)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1 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
- NCT03297450
- Sponsor's protocol ID
- EC2017/0906
- Status last verified
- Jan 2023
- First submitted
- 5 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 (tDCS) with Aphasia Therapy in the Acute Phase After Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03297450
- Acronym / sponsor ID
- EC2017/0906
- Conditions
- Aphasia Following Cerebral Infarction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult patient recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 29 Sep 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 acute stage 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 acute 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
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- aphasia therapy (45 minutes) in combination with (sham or real) tDCS (20 minutes)
| Arm | Type | Receives |
|---|---|---|
| Aphasia therapy and tDCS | Active comparator | Device: tDCS, Behavioral: Aphasia therapy |
| Aphasia therapy and sham-tDCS | Sham comparator | Behavioral: Aphasia therapy, Device: Sham-tDCS |
| Standard of care and sham-tDCS | Sham comparator | Device: Sham-tDCS |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with mild-moderate aphasia (Token Test Score between 7 and 40)
- Inclusion in the first few days after stroke (acute phase)
- Age 18 - 85 years
- Being right-handed
- Mothertongue: Dutch
Key exclusion criteria (4 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 anamneses)
- Prior brain surgery
- Excessive use of alcohol or drugs
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 | Device | Aphasia therapy and tDCS |
| Aphasia therapyBased on linguistic tests, individualized aphasia therapy will be provided | Behavioural | Aphasia therapy and sham-tDCS, Aphasia therapy and tDCS |
| Sham-tDCStDCS during the first 20 minutes of aphasia therapy at an intensity of 0mA (Sham) | Device | Aphasia therapy and sham-tDCS, Standard of care and sham-tDCS |
Primary outcome
Change in naming performance
Time frame: baseline, 1 week, 3 months, 6 months
Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 and 6 months
Change in Vital Parameters
Time frame: baseline, 1 hour (each session)
Blood pressure and heart rate will be measured before and after each session of treatment
3 secondary outcomes
Change in tolerability (Visual analogue scale)
Time frame: baseline, 1 hour (each session)
Change in Spontaneous Speech
Time frame: baseline, 1 week, 3 months, 6 months
Change in ERPs
Time frame: baseline, 1 week, 3 months, 6 months
Results and safety
The study was stopped early (reason given: Difficult patient recruitment). 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
Related trials for Aphasia Following Cerebral Infarction
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia
Aphasia Following Cerebral Infarction, Stroke Ischemic
RecruitingPhase 2
Comparing Traditional Semantic Feature Analysis (tSFA) and Semantic Feature Analysis + Metacognitive Strategy Training (SFA+MST)
Aphasia, Aphasia Following Cerebral Infarction
RecruitingPhase 2
Transcranial Magnetic Stimulation + Language Therapy to Treat Subacute Aphasia
Stroke, Aphasia
Not yet recruiting
Intensive Comprehensive Aphasia Programme for People With Post-Stroke Aphasia
Aphasia Following Cerebral Infarction
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 study testing tDCS and Aphasia therapy in people with Aphasia Following Cerebral Infarction, 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 8 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: 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.
Are results available for this study?
The study was stopped early (reason given: Difficult patient recruitment). 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 (time frame: baseline, 1 week, 3 months, 6 months). 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?
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.