Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Szzx201509 | Other Grant/Funding Number | Suzhou Key Medical Center for Psychiatric Diseases | |
| SS201752 | Other Grant/Funding Number | Scientific and Technological Program of Suzhou |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study was to evaluate the efficacy, safety, and cognitive function of transcranial direct current stimulation (tDCS) in chronic schizophrenia patients with tardive dyskinesia (TD).
This study is a randomized, double-blind, sham-controlled clinical trial. 60 patients with TD were randomly allocated to active (n=30) or sham tDCS groups (n=30). All patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment). Abnormal Involuntary Movements Scale (AIMS), Tardive Dyskinesia Rating Scale (TDRS), Assessment of Negative Symptoms(SANS), the Positive and Negative symptom scale(PANSS), and the Cambridge Neuropsychological Test Automatic Battery (CANTAB) were assessed in patients. All evaluations were scored at baseline, the end of 3rd weeks, 5th weeks, and 7th weeks. Side effects of tDCS were assessed with an experimenter-administered open-ended questionnaire during the whole experiment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | All patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment). |
|
| Sham tDCS | Sham Comparator | For sham stimulation, the device was set to turn off after 30 seconds(study model). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS | Device | All patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal Involuntary Movements Scale | The primary outcome measure was the severity of TD symptoms, which was measured by the AIMS total score(the sum of items 1-7).The range for subscale scores(items1-7) is between 0-28 scores and the higher values represent a worse outcome. | Change from baseline AIMS(items1-7) total scores at 3 weeks and 5 weeks and 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tardive Dyskinesia Rating Scale | The severity of TD symptoms were also measured by the total TDRS score and the orofacial dyskinesia subscale scores, trunk and limb dyskinesia subscale scores. The range for TDRS total score is between 44-264 scores and the orofacial dyskinesia subscale scores are between16-96 scores , the trunk and limb dyskinesia subscale scores are between 24-144 scores.The higher values represent a worse outcome. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guangzhong Yin, MD | Suzhou Guangji Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suzhou Psychiatric Hospital | Suzhou | Jiangsu | 215137 | China | ||
| Suzhou |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37620825 | Derived | Zhou Y, Xia X, Zhao X, Yang R, Wu Y, Liu J, Lyu X, Li Z, Zhang G, Du X. Efficacy and safety of Transcranial Direct Current Stimulation (tDCS) on cognitive function in chronic schizophrenia with Tardive Dyskinesia (TD): a randomized, double-blind, sham-controlled, clinical trial. BMC Psychiatry. 2023 Aug 24;23(1):623. doi: 10.1186/s12888-023-05112-0. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2020 | Dec 11, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 1, 2017 | Aug 19, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000071057 | Tardive Dyskinesia |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D004409 | Dyskinesia, Drug-Induced |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
The aim of the study was to evaluate the efficacy, safety, and cognitive function of transcranial direct current stimulation (tDCS) in chronic schizophrenia patients with tardive dyskinesia (TD).
Not provided
Not provided
This study is a randomized, double-blind, sham-controlled clinical trial.All patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment). All evaluations were performed at baseline, the end of 3rd weeks, 5th weeks, and 7th weeks by 2 psychiatrists blinded to the treatment assigned. Inter-rater reliability was satisfactory(ka=0.86).
| Sham tDCS | Device | For sham stimulation, the device was set to turn off after 30 seconds(study model). |
|
| Change from baseline TDRS total scores at 3 weeks and 5 weeks and 7 weeks |
| Safety and Tolerabilit | Side effects of tDCS were assessed with an experimenter-administered open-ended questionnaire during the whole experiment. The questionnaire contained rating scales regarding the presence and severity of headache, difficulties in concentrating, acute mood changes, visual perceptual changes and any discomforting sensation like pain, tingling, itching or burning under the electrodes. | We assessed the side affects during and after tDCS. |
| Scale for the Assessment of Negative Symptoms | Negative symptoms were assessed with SANS. The range for SANS total scores is between 0-120 scores and the higher values represent a worse outcome. | Change from baseline SANS total scores at 5 weeks |
| Positive and Negative symptom scale | Psychopathology was measured by the total PANSS score and the positive, negative, and general psychopathology subscale scores. The range for PANSS total score is between 30-210 scores and the positive subscale scores are between 7-49 scores and the negative subscale scores are between 7-49 scores and the general psychopathology total scores are between 16-112 scores. | Change from baseline PANSS total scores at 5 weeks |
| Cambridge Neuropsychological Test Automatic Battery | Each patient was given a series of computerized tests from the Cambridge Neuropsychological Test Automated Battery. The language-independent tests and touch screen technology deliver rapid and non-invasive cognitive assessment. Executive and memory function were assessed with the following three tasks:The Pattern Recognition Memory (PRM), Intra/Extradimensional Set Shift (IED), and Spatial Working Memory. | Change from baseline cognitive function at 3 weeks and 5 weeks and 7 weeks |
| Suzhou |
| Jiangsu |
| 215237 |
| China |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |