StrokePhase 4NCT01200719
Transcranial Alternating Current Stimulation
A Phase 4 study testing transcranial alternating current stimulation (tACS) in people with Stroke, run by Fudan University at 1 site in China.
Trial summary
To investigate the efficacy of using transcranial alternating current stimulation (tACS) to enhance the regaining of neurological function among post-stroke patients. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Stroke
- What is being tested?
- transcranial alternating current stimulation (tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- Nov 2006to Sep 2009
- Phase
- Phase 4
- 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 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed as first onset intracerebral haemorrhage or infarction (according to ICD-10 I61.0-I61.6 or I63.3-I63.6, with or without I69, i.e.: sequelae of cerebrovascular disease)
- between 15 and 60 days after the onset
- right handedness
- no previous neurological or psychiatric disorders
- positive transtemporal windows for bilateral middle, anterior, and posterior cerebral arteries insonation (according to the standards set by the Transcranial Doppler Ultrasonographic Device (TCD))
- NIH Stroke Scale (NIHSS) scores between 14 and 24
- not receiving rehabilitation before admission
Who cannot join
- medical comorbidity preventing the patient undergoing the intervention
- preceding epileptic fits
- having metallic implants in the brain or a pacemaker
- history of surgery to the brain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Alternating Current Stimulation (tACS) Enhances Neurological Function Recovery Among Post-stroke Patients
To investigate the efficacy of using transcranial alternating current stimulation (tACS) to enhance the regaining of neurological function among post-stroke patients.
Read the detailed description
Sixty post-stroke patients were randomly assigned to receive 15 sessions of the usual rehabilitation programme with or without tACS. The NIH Stroke Scale (NIHSS) and the mean blood flow velocity (MFV) and Gosling pulsatility index (PI) captured for the middle, anterior, and posterior cerebral artery were the outcome measures.
Fifteen 30-minute sessions of tACS appear to be effective for enhancing post-stroke patients' neurological function. The haemodynamic measures taken indicated that the regaining of function among the patients was largely attributed to a lowering of the vascular autoregulatory activity together with an increase in blood flow velocity at the middle cerebral artery. Future studies should explore the underlying mechanisms mediating the positive effects brought about by tACS in post-stroke rehabilitation.
- Conditions
- Stroke
- Being tested
- transcranial alternating current stimulation (tACS)
- Keywords
- brain electrical stimulation, sub-acute post-stroke, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial alternating current stimulation (tACS)Device
Also called CVFT-MG201(China Patent No. ZL98121951.9)
Patients in the tACS group received a total of 15 sessions of brain stimulation. The sessions were conducted on weekdays (from Monday to Friday) for three consecutive weeks. Each session lasted 30 minutes. The alternating current stimulations were generated by a CVFT-MG201 machine. Stimulations were delivered by two U-shaped electrodes (approximately 7 cm2) fixed on the patient's left and right mastoid regions (anode or cathode varied depending on polarity of the alternating current). The frequencies (supra-slow waves: < 1 Hz; theta to gamma), levels of intensities (0 to 3mA), and density function (follows a bell-shaped curve; mean intensity ~ 2.1mA) of the current were delivered according to the manufacturer's pre-set random protocol.
| Study group | Role | What they receive |
|---|---|---|
| tACS group | Experimental | Not described Receives: Device: transcranial alternating current stimulation (tACS) |
| Control group | No intervention | Patients in the control group followed exactly the same protocol but without receiving the transcranial alternating current stimulation . |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH Stroke Scale (NIHSS) score
Measured: 3 weeks
Secondary outcomes (2)
the mean blood flow velocity (MFV)
captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler
Measured: 30 minutes
Gosling pulsatility index (PI)
captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startNov 2006
- Primary completionJun 2007
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fudan 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Investigators
- Yongshan Hu, MD, Principal investigator, Rehabilitation Center, Huashan Hospital of Fudan University, Shanghai, ChinaChetwyn Chan, PhD, Study director, Department of Rehabilitation Science, the Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200719
- Sponsor's protocol ID
- 2006-102
- Status last verified
- Oct 2006
- First submitted
- 10 Sep 2010
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Alternating Current Stimulation (tACS) Enhances Neurological Function Recovery Among Post-stroke Patients
- ClinicalTrials.gov ID
- NCT01200719
- Acronym / sponsor ID
- 2006-102
- Conditions
- Stroke
- Keywords
- brain electrical stimulation, sub-acute post-stroke, rehabilitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- Nov 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 14 Sep 2010 (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 efficacy of using transcranial alternating current stimulation (tACS) to enhance the regaining of neurological function among post-stroke patients.
Detailed description
Sixty post-stroke patients were randomly assigned to receive 15 sessions of the usual rehabilitation programme with or without tACS. The NIH Stroke Scale (NIHSS) and the mean blood flow velocity (MFV) and Gosling pulsatility index (PI) captured for the middle, anterior, and posterior cerebral artery were the outcome measures.
Fifteen 30-minute sessions of tACS appear to be effective for enhancing post-stroke patients' neurological function. The haemodynamic measures taken indicated that the regaining of function among the patients was largely attributed to a lowering of the vascular autoregulatory activity together with an increase in blood flow velocity at the middle cerebral artery. Future studies should explore the underlying mechanisms mediating the positive effects brought about by tACS in post-stroke rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tACS group | Experimental | Device: transcranial alternating current stimulation (tACS) |
| Control group | No intervention | –Patients in the control group followed exactly the same protocol but without receiving the transcranial alternating current stimulation . |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diagnosed as first onset intracerebral haemorrhage or infarction (according to ICD-10 I61.0-I61.6 or I63.3-I63.6, with or without I69, i.e.: sequelae of cerebrovascular disease)
- between 15 and 60 days after the onset
- right handedness
- no previous neurological or psychiatric disorders
- positive transtemporal windows for bilateral middle, anterior, and posterior cerebral arteries insonation (according to the standards set by the Transcranial Doppler Ultrasonographic Device (TCD))
Key exclusion criteria (4 listed)
- medical comorbidity preventing the patient undergoing the intervention
- preceding epileptic fits
- having metallic implants in the brain or a pacemaker
- history of surgery to the brain
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 |
|---|---|---|
| transcranial alternating current stimulation (tACS)Also: CVFT-MG201(China Patent No. ZL98121951.9)Patients in the tACS group received a total of 15 sessions of brain stimulation. The sessions were conducted on weekdays (from Monday to Friday) for three consecutive weeks. Each session lasted 30 minutes. The alternating current stimulations were generated by a CVFT-MG201 machine. Stimulations were delivered by two U-shaped electrodes (approximately 7 cm2) fixed on the patient's left and right mastoid regions (anode or cathode varied depending on polarity of the alternating current). The frequencies (supra-slow waves: < 1 Hz; theta to gamma), levels of intensities (0 to 3mA), and density function (follows a bell-shaped curve; mean intensity ~ 2.1mA) of the current were delivered according to the manufacturer's pre-set random protocol. | Device | tACS group |
Primary outcome
NIH Stroke Scale (NIHSS) score
Time frame: 3 weeks
2 secondary outcomes
the mean blood flow velocity (MFV)
Time frame: 30 minutes
Gosling pulsatility index (PI)
Time frame: 30 minutes
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 14 Sep 2010.
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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.
Yongshan Hu, MD principal investigator
Rehabilitation Center, Huashan Hospital of Fudan University, Shanghai, China
Chetwyn Chan, PhD study director
Department of Rehabilitation Science, the Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing transcranial alternating current stimulation (tACS) in people with Stroke, run by Fudan University at 1 site in China.
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 7 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 14 Sep 2010. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
NIH Stroke Scale (NIHSS) score (time frame: 3 weeks). 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 14 Sep 2010.