Transcranial Alternating Current Stimulation
This study has been completed.
Sponsor:
Fudan University
Collaborator:
The Hong Kong Polytechnic University
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01200719
First received: September 10, 2010
Last updated: September 13, 2010
Last verified: October 2006
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 10, 2010 | ||||||||
| Last Updated Date | September 13, 2010 | ||||||||
| Start Date ICMJE | November 2006 | ||||||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
NIH Stroke Scale (NIHSS) score [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01200719 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Transcranial Alternating Current Stimulation | ||||||||
| Official Title ICMJE | Transcranial Alternating Current Stimulation (tACS) Enhances Neurological Function Recovery Among Post-stroke Patients | ||||||||
| Brief Summary | To investigate the efficacy of using transcranial alternating current stimulation (tACS) to enhance the regaining of neurological function among post-stroke patients. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Stroke | ||||||||
| Intervention ICMJE | Device: 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 Name: CVFT-MG201(China Patent No. ZL98121951.9) |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 312 | ||||||||
| Completion Date | September 2009 | ||||||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 40 Years to 79 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01200719 | ||||||||
| Other Study ID Numbers ICMJE | 2006-102 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Yongshan Hu, Head of Rehabilitation Center, Huashan Hospital of Fudan University | ||||||||
| Study Sponsor ICMJE | Fudan University | ||||||||
| Collaborators ICMJE | The Hong Kong Polytechnic University | ||||||||
| Investigators ICMJE |
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| Information Provided By | Fudan University | ||||||||
| Verification Date | October 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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