Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
312 participants
INTERVENTIONAL
2006-11-30
2009-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
tACS group
transcranial alternating current stimulation (tACS)
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.
Control group
Patients in the control group followed exactly the same protocol but without receiving the transcranial alternating current stimulation .
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
transcranial alternating current stimulation (tACS)
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* preceding epileptic fits
* having metallic implants in the brain or a pacemaker
* history of surgery to the brain
40 Years
79 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Hong Kong Polytechnic University
OTHER
Fudan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Huashan Hospital of Fudan University
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yongshan Hu, MD
Role: PRINCIPAL_INVESTIGATOR
Rehabilitation Center, Huashan Hospital of Fudan University, Shanghai, China
Chetwyn Chan, PhD
Role: STUDY_DIRECTOR
Department of Rehabilitation Science, the Hong Kong Polytechnic University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Huashan Hospital
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2006-102
Identifier Type: -
Identifier Source: org_study_id