Non Fluent Aphasia in Subacute StrokeNCT01850836
Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia
A study testing repetitive transcranial magnetic stimulation in people with Non Fluent Aphasia in Subacute Stroke, run by Assiut University.
Trial summary
To investigate the therapeutic effect of dual hemisphere repetitive transcranial magnetic stimulation (rTMS) on post-stroke non fluent aphasia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Non Fluent Aphasia in Subacute Stroke
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Jan 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- acute hemiplegia with non-fluent aphasia, single thromboembolic non-haemorrhagic infarction documented by computerized tomography (CT) in the distribution of middle cerebral artery.
Who cannot join
- head injury or neurological disease other than stroke,
- Unstable cardiac dysrhythmia,
- Fever,
- Infection,
- Hyperglycaemia
- Prior administration of tranquilizer
- Patients with no motor evoked response recorded from first dorsal interosseus (FDI) muscle of the affected hand
About this study
Official title: Treatment of Aphasic Stroke Patients With rTMS
To investigate the therapeutic effect of dual hemisphere repetitive transcranial magnetic stimulation (rTMS) on post-stroke non fluent aphasia.
Read the detailed description
Thirty patients with subacute post-stroke non-fluent aphasia were randomly allocated with a ratio 2:1 to receive real (n = 20) or sham (n = 10) rTMS of the affected motor cortex. Each patient received 1000 rTMS pulses (1 Hertz at 110% of resting motor threshold) over the unaffected Broca's area and 1000 pulses (20 Hertz at 100% resting motor threshold) over affected left Broca's area for 10 consecutive days. LANGUAGE section of hemispheric stroke scale, Stroke Aphasic Depression Questionnaire Hospital Version (SADQ-H) and NIH stroke scale were assessed before, post sessions, 1 and 2 months after the last session . Motor threshold was assessed before and after the end of last session.
- Conditions
- Non Fluent Aphasia in Subacute Stroke
- Being tested
- repetitive transcranial magnetic stimulation
- Keywords
- Aphasia, Stroke, repetitive transcranial magnetic stimulation.
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationProcedure or surgery
Also called rTMS
| Study group | Role | What they receive |
|---|---|---|
| Real rTMS | Active comparator | 19 subacute stroke pts with aphasia received 10 rTMS (5sessions/week) for 2 successive weeks Receives: Procedure: repetitive transcranial magnetic stimulation |
| Sham rTMS | Sham comparator | 10 patients received sham rTMS stimulation (5 sessions/week) for 2 successive weeks Receives: Procedure: repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemispheric stroke scale (HSS)
Language assessment using hemispheric stroke scale (HSS)
Measured: Change from Baseline in HSS at 2 months
Secondary outcomes (1)
NIH Stroke Scale (NIHSS)
Measured: Change from Baseline in NIHSS at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startDec 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Fluent Aphasia in Subacute StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman M. Khedr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850836
- Sponsor's protocol ID
- rTMS in Rehab of aphasia
- Status last verified
- May 2013
- First submitted
- 12 Mar 2013
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Aphasic Stroke Patients With rTMS
- ClinicalTrials.gov ID
- NCT01850836
- Acronym / sponsor ID
- rTMS in Rehab of aphasia
- Conditions
- Non Fluent Aphasia in Subacute Stroke
- Keywords
- Aphasia, Stroke, repetitive transcranial magnetic stimulation.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 May 2013 (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.
To investigate the therapeutic effect of dual hemisphere repetitive transcranial magnetic stimulation (rTMS) on post-stroke non fluent aphasia.
Detailed description
Thirty patients with subacute post-stroke non-fluent aphasia were randomly allocated with a ratio 2:1 to receive real (n = 20) or sham (n = 10) rTMS of the affected motor cortex. Each patient received 1000 rTMS pulses (1 Hertz at 110% of resting motor threshold) over the unaffected Broca's area and 1000 pulses (20 Hertz at 100% resting motor threshold) over affected left Broca's area for 10 consecutive days. LANGUAGE section of hemispheric stroke scale, Stroke Aphasic Depression Questionnaire Hospital Version (SADQ-H) and NIH stroke scale were assessed before, post sessions, 1 and 2 months after the last session . Motor threshold was assessed before and after the end of last session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real rTMS | Active comparator | Procedure: repetitive transcranial magnetic stimulation19 subacute stroke pts with aphasia received 10 rTMS (5sessions/week) for 2 successive weeks |
| Sham rTMS | Sham comparator | Procedure: repetitive transcranial magnetic stimulation10 patients received sham rTMS stimulation (5 sessions/week) for 2 successive weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- acute hemiplegia with non-fluent aphasia, single thromboembolic non-haemorrhagic infarction documented by computerized tomography (CT) in the distribution of middle cerebral artery.
Key exclusion criteria (7 listed)
- head injury or neurological disease other than stroke,
- Unstable cardiac dysrhythmia,
- Fever,
- Infection,
- Hyperglycaemia
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 |
|---|---|---|
| repetitive transcranial magnetic stimulationAlso: rTMS | Procedure or surgery | Real rTMS, Sham rTMS |
Primary outcome
Hemispheric stroke scale (HSS)
Time frame: Change from Baseline in HSS at 2 months
Language assessment using hemispheric stroke scale (HSS)
1 secondary outcome
NIH Stroke Scale (NIHSS)
Time frame: Change from Baseline in NIHSS at 2 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 10 May 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation in people with Non Fluent Aphasia in Subacute Stroke, run by Assiut University.
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 1 inclusion and 7 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 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Hemispheric stroke scale (HSS) (time frame: Change from Baseline in HSS at 2 months). 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 10 May 2013.