StrokePhase 2NCT02514044
Dextroamphetamine and tDCS to Improve the Fluency
A Phase 2 study testing Dexedrine, Active tDCS and Speech Therapy in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The proposed study aims to evaluate safety and efficacy of combined dextroamphetamine (Dexedrine) and transcranial direct current stimulation (tDCS) with melodic intonation therapy (MIT) for treatment of aphasia after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Dexedrine, Active tDCS and Speech 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18
- Native English proficiency;
- Nonfluent speech;
- Premorbid right handedness;
- Non-hemorrhagic left hemispheric stroke at least 6 months prior to the investigation.
- No contraindications for MRI (only subjects who will undergo MRI scan).
Who cannot join
- Hypersensitivity or idiosyncrasy to dextroamphetamine or to other sympathomimetic agents;
- Pregnant or trying to become pregnant;
- Active alcohol abuse, illicit drug use or drug abuse or significant mental illness;
- Subjects receiving alpha adrenergic antagonists or agonists;
- Any history of epilepsy;
- Any condition that would prevent the subject from giving voluntary informed consent;
Show all 19Show fewer
- An implanted brain stimulator;
- Aneurysm clip or other metal in the brain;
- Enrolled or plans to enroll in an interventional trial during this study;
- Scalp wounds or infections;
- Previous stroke with residual deficits (TIAs not a reason for exclusion);
- A concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition;
- Advanced atherosclerosis, Unstable cardiac dysrhythmia or uncontrolled hypertension (>160/100 mm Hg), or untreated hyperthyroidism;
- Diagnosis of glaucoma
- During or within 14 days following the administration of monoamine oxidase inhibitors;
- Subjects requiring palliative care;
- Terminal medical condition such as AIDS or cancer;
- Subjects unable to comprehend or follow verbal commands;
- Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition;
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center
Houston, Texas, 77030
About this study
Official title: Transcranial Direct Current Stimulation and Melodic Intonation Therapy Combined With Dextroamphetamine in Chronic Stroke Patients With Non-fluent Aphasia; Safety and Efficacy Phase
The proposed study aims to evaluate safety and efficacy of combined dextroamphetamine (Dexedrine) and transcranial direct current stimulation (tDCS) with melodic intonation therapy (MIT) for treatment of aphasia after stroke. The target population is patients with chronic speech deficits due to a left hemisphere non-hemorrhagic stroke. Findings from this proposed project will help in the design of future larger studies.The safety phase will use cross-over, placebo controlled and single-blinded design. 10 participants with post stroke chronic non-fluent aphasia will undergo two experiments. To study the safety and effect of combined dextroamphetamine, tDCS and MIT therapy the study will use a parallel-groups, randomized, sham and placebo controlled, and double-blinded design in which 48 participants with post stroke chronic non-fluent aphasia will be randomly assigned to receive either 1) dextroamphetamine therapy with active stimulation, 2) placebo medication with active stimulation, 3) dextroamphetamine therapy with sham stimulation or 4) placebo medication with sham stimulation for the same duration.
Read the detailed description
Two phases were planned for this study, as described below. The safety phase of the study was completed; however, due to limited funding, the efficacy phase was never started (that is, the efficacy phase was terminated).
SAFETY PHASE: The safety phase will use cross-over, placebo controlled and single-blinded design. 10 participants with post stroke chronic non-fluent aphasia will undergo two experiments. In the experiment 1, the subjects will receive 10 mg dextroamphetamine, 1.5 mA anodal tDCS to right inferior frontal gyrus (right Broca's area), and melodic intonation therapy. The two experiments of one time intervention will be separated by 1 week of washout and when the subjects come back for experiment 2, any later side effects will be evaluated. In the experiment 2, the subjects will receive placebo medication with anodal tDCS to right IFG (Broca's area) and melodic intonation therapy. During the experiments, thirty minutes before stimulation, participants in the active drug experiment (n=10) will take 10 mg dextroamphetamine per oral -experiment 1- and participants in the placebo drug experiment will take placebo pill per oral -experiment 2-. During the 20 minute stimulation phase, the participants (n=10) will receive anodal tDCS (1.5 mA) on ipsilesional right inferior frontal gyrus (Broca's area). All participants will simultaneously receive melodic intonation therapy for duration of an hour during and after 20 minutes of stimulation.
EFFICACY PHASE: To study the safety and effect of combined dextroamphetamine, tDCS and MIT therapy the study will use a parallel-groups, randomized, sham and placebo controlled, and double-blinded design in which 48 participants with post stroke chronic non-fluent aphasia will be randomly assigned to receive either 1) dextroamphetamine therapy with active stimulation, 2) placebo medication with active stimulation, 3) dextroamphetamine therapy with sham stimulation or 4) placebo medication with sham stimulation for the same duration. The subjects from the previous step of the study will be asked to participate to this step. Thirty minutes before stimulation participants in the active drug groups, group 1 (n=12) and group 3 (n=12) will take dextroamphetamine 10 mg per oral and participants in the placebo groups, group 2 (n=12) and group 4 (n=12) will take placebo pill per oral. During the 20 minute stimulation phase, the participants in the active stimulation groups, groups 1 (n=12) and 2 (n=12) will receive anodal tDCS (1.5 mA) on right inferior frontal gyrus (Broca's area), and participants in the sham control groups, group 3 (n=12) and group 4 (n=12) will receive sham stimulation. All participants will simultaneously receive melodic intonation therapy for duration of an hour during and after 20 minutes of stimulation. Treatment will be administered at an intensity of 5 sessions per week for 2 weeks.
- Conditions
- Stroke
- Being tested
- Dexedrine, Active tDCS, Speech Therapy, Placebo, Sham tDCS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexedrineDrug
Also called Adderall, Dexedrine
10 mg immediate release of Dexedrine
Active tDCSDevice
1.5 mA tDCS anodal tDCS
Speech TherapyBehavioural
Also called Melodic Intonation Therapy
60 min of speech therapy
PlaceboDrug
Sham tDCSDevice
| Study group | Role | What they receive |
|---|---|---|
| Dexedrine+sham tDCS+speech therapy | Experimental | 10 mg Dexedrine and speech therapy for 10 days Receives: Drug: Dexedrine; Behavioral: Speech Therapy; Device: Sham tDCS |
| active tDCS+placebo+speech therapy | Experimental | 1.5 mA anodal tDCS and speech therapy for 10 days Receives: Device: Active tDCS; Behavioral: Speech Therapy; Drug: Placebo |
| Dexedrine+tDCS+speech therapy | Experimental | 10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 10 days Receives: Drug: Dexedrine; Device: Active tDCS; Behavioral: Speech Therapy |
| sham stimulation+placebo+speech therapy | Experimental | Sham stimulation, placebo and speech therapy for 10 days Receives: Behavioral: Speech Therapy; Drug: Placebo; Device: Sham tDCS |
| Dexedrine+tDCS+Speech Therapy | Experimental | 10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 1 day Receives: Drug: Dexedrine; Device: Active tDCS; Behavioral: Speech Therapy |
| placebo+tDCS+Speech Therapy | Experimental | 1.5 mA anodal tDCS, and speech therapy for 1 day Receives: Device: Active tDCS; Behavioral: Speech Therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Language Quotient as Assessed by the Western Aphasia Battery
The score on the Language Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.
Measured: immediately before the treatment, immediately after the treatment
Percent Change in Aphasia Quotient as Assessed by the Western Aphasia Battery
The score on the Aphasia Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.
Measured: immediately before the treatment, immediately after the treatment
Secondary outcomes (3)
Boston Diagnostic Aphasia Examination
Measured: Baseline,2 weeks
Boston Diagnostic Aphasia Examination
Measured: Baseline,2 months
Percent Change in Blood Pressure
Non-invasive BP measurements performed by a clinician before and after each experiment.
Measured: immediately before the treatment, after after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerard Francisco, The University of Texas Health Science Center, Houston
- Investigators
- Gerard E Francisco, MD, Principal investigator, University of Texas Health Science Center at Houston, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514044
- Sponsor's protocol ID
- HSC-MS-14-0354
- Status last verified
- Jul 2018
- First submitted
- 4 Jun 2015
- Last updated
- 3 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation and Melodic Intonation Therapy Combined With Dextroamphetamine in Chronic Stroke Patients With Non-fluent Aphasia; Safety and Efficacy Phase
- ClinicalTrials.gov ID
- NCT02514044
- Acronym / sponsor ID
- HSC-MS-14-0354
- Conditions
- Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Aug 2015 (estimated)
- Results
- Posted 3 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study aims to evaluate safety and efficacy of combined dextroamphetamine (Dexedrine) and transcranial direct current stimulation (tDCS) with melodic intonation therapy (MIT) for treatment of aphasia after stroke. The target population is patients with chronic speech deficits due to a left hemisphere non-hemorrhagic stroke. Findings from this proposed project will help in the design of future larger studies.The safety phase will use cross-over, placebo controlled and single-blinded design. 10 participants with post stroke chronic non-fluent aphasia will undergo two experiments. To study the safety and effect of combined dextroamphetamine, tDCS and MIT therapy the study will use a parallel-groups, randomized, sham and placebo controlled, and double-blinded design in which 48 participants with post stroke chronic non-fluent aphasia will be randomly assigned to receive either 1) dextroamphetamine therapy with active stimulation, 2) placebo medication with active stimulation, 3) dextroamphetamine therapy with sham stimulation or 4) placebo medication with sham stimulation for the same duration.
Detailed description
Two phases were planned for this study, as described below. The safety phase of the study was completed; however, due to limited funding, the efficacy phase was never started (that is, the efficacy phase was terminated).
SAFETY PHASE: The safety phase will use cross-over, placebo controlled and single-blinded design. 10 participants with post stroke chronic non-fluent aphasia will undergo two experiments. In the experiment 1, the subjects will receive 10 mg dextroamphetamine, 1.5 mA anodal tDCS to right inferior frontal gyrus (right Broca's area), and melodic intonation therapy. The two experiments of one time intervention will be separated by 1 week of washout and when the subjects come back for experiment 2, any later side effects will be evaluated. In the experiment 2, the subjects will receive placebo medication with anodal tDCS to right IFG (Broca's area) and melodic intonation therapy. During the experiments, thirty minutes before stimulation, participants in the active drug experiment (n=10) will take 10 mg dextroamphetamine per oral -experiment 1- and participants in the placebo drug experiment will take placebo pill per oral -experiment 2-. During the 20 minute stimulation phase, the participants (n=10) will receive anodal tDCS (1.5 mA) on ipsilesional right inferior frontal gyrus (Broca's area). All participants will simultaneously receive melodic intonation therapy for duration of an hour during and after 20 minutes of stimulation.
EFFICACY PHASE: To study the safety and effect of combined dextroamphetamine, tDCS and MIT therapy the study will use a parallel-groups, randomized, sham and placebo controlled, and double-blinded design in which 48 participants with post stroke chronic non-fluent aphasia will be randomly assigned to receive either 1) dextroamphetamine therapy with active stimulation, 2) placebo medication with active stimulation, 3) dextroamphetamine therapy with sham stimulation or 4) placebo medication with sham stimulation for the same duration. The subjects from the previous step of the study will be asked to participate to this step. Thirty minutes before stimulation participants in the active drug groups, group 1 (n=12) and group 3 (n=12) will take dextroamphetamine 10 mg per oral and participants in the placebo groups, group 2 (n=12) and group 4 (n=12) will take placebo pill per oral. During the 20 minute stimulation phase, the participants in the active stimulation groups, groups 1 (n=12) and 2 (n=12) will receive anodal tDCS (1.5 mA) on right inferior frontal gyrus (Broca's area), and participants in the sham control groups, group 3 (n=12) and group 4 (n=12) will receive sham stimulation. All participants will simultaneously receive melodic intonation therapy for duration of an hour during and after 20 minutes of stimulation. Treatment will be administered at an intensity of 5 sessions per week for 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dexedrine+sham tDCS+speech therapy | Experimental | Drug: Dexedrine, Behavioral: Speech Therapy, Device: Sham tDCS10 mg Dexedrine and speech therapy for 10 days |
| active tDCS+placebo+speech therapy | Experimental | Device: Active tDCS, Behavioral: Speech Therapy, Drug: Placebo1.5 mA anodal tDCS and speech therapy for 10 days |
| Dexedrine+tDCS+speech therapy | Experimental | Drug: Dexedrine, Device: Active tDCS, Behavioral: Speech Therapy10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 10 days |
| sham stimulation+placebo+speech therapy | Experimental | Behavioral: Speech Therapy, Drug: Placebo, Device: Sham tDCSSham stimulation, placebo and speech therapy for 10 days |
| Dexedrine+tDCS+Speech Therapy | Experimental | Drug: Dexedrine, Device: Active tDCS, Behavioral: Speech Therapy10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 1 day |
| placebo+tDCS+Speech Therapy | Experimental | Device: Active tDCS, Behavioral: Speech Therapy, Drug: Placebo1.5 mA anodal tDCS, and speech therapy for 1 day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age above 18
- Native English proficiency;
- Nonfluent speech;
- Premorbid right handedness;
- Non-hemorrhagic left hemispheric stroke at least 6 months prior to the investigation.
Key exclusion criteria (19 listed)
- Hypersensitivity or idiosyncrasy to dextroamphetamine or to other sympathomimetic agents;
- Pregnant or trying to become pregnant;
- Active alcohol abuse, illicit drug use or drug abuse or significant mental illness;
- Subjects receiving alpha adrenergic antagonists or agonists;
- Any history of epilepsy;
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 |
|---|---|---|
| DexedrineAlso: Adderall, Dexedrine10 mg immediate release of Dexedrine | Drug | Dexedrine+sham tDCS+speech therapy, Dexedrine+tDCS+Speech Therapy, Dexedrine+tDCS+speech therapy |
| Active tDCS1.5 mA tDCS anodal tDCS | Device | Dexedrine+tDCS+Speech Therapy, Dexedrine+tDCS+speech therapy, active tDCS+placebo+speech therapy, placebo+tDCS+Speech Therapy |
| Speech TherapyAlso: Melodic Intonation Therapy60 min of speech therapy | Behavioural | Dexedrine+sham tDCS+speech therapy, Dexedrine+tDCS+Speech Therapy, Dexedrine+tDCS+speech therapy, active tDCS+placebo+speech therapy, placebo+tDCS+Speech Therapy, sham stimulation+placebo+speech therapy |
| Placebo | Drug | active tDCS+placebo+speech therapy, placebo+tDCS+Speech Therapy, sham stimulation+placebo+speech therapy |
| Sham tDCS | Device | Dexedrine+sham tDCS+speech therapy, sham stimulation+placebo+speech therapy |
Primary outcome
Percent Change in Language Quotient as Assessed by the Western Aphasia Battery
Time frame: immediately before the treatment, immediately after the treatment
The score on the Language Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.
Percent Change in Aphasia Quotient as Assessed by the Western Aphasia Battery
Time frame: immediately before the treatment, immediately after the treatment
The score on the Aphasia Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.
3 secondary outcomes
Boston Diagnostic Aphasia Examination
Time frame: Baseline,2 weeks
Boston Diagnostic Aphasia Examination
Time frame: Baseline,2 months
Percent Change in Blood Pressure
Time frame: immediately before the treatment, after after the treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gerard E Francisco, MD principal investigator
University of Texas Health Science Center at Houston, Department of Physical Medicine and Rehabilitation
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 Dexedrine, Active tDCS and Speech Therapy in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 19 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 Aug 2018. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Language Quotient as Assessed by the Western Aphasia Battery (time frame: immediately before the treatment, immediately after the treatment). 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 3 Aug 2018.