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NCT05622552
Effect of tDCS Combined With Pharmacological Treatments for Bipolar Mania
NA trial testing active group of tDCS in Manic Episode in 70 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Dongbin Lyu |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 1 October 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- active group of tDCS
- sham group of tDCS
Conditions studied
- Manic Episode — all drugs for Manic Episode →
Sponsor
Dongbin Lyu
Who can join
Adults 18 to 65, any sex, with Manic Episode. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to conduct a randomized double-blind controlled trial to explore the efficacy and safety of transcranial direct current stimulation (tDCS) in the treatment of manic episode (ME) and analyzes the brain functional connectivity to construct the therapeutic effect prediction model of tDCS for ME. The main questions it aims to answer are: * A randomized double-blind controlled trial is conducted to clarify the efficacy and safety of tDCS combined with pharmacological treatments in the ME. * A therapeutic effect prediction model of tDCS for ME by using functional near-infrared spectroscopy to evaluate brain function. Participants will be receive: * clinical data interview and clinical symptom assessment. * the functional near-infrared spectroscopy (fNIRS) to analysis brain functional connectivity. * tDCS stimulation, which was performed once a day sessions of active or sham anodal tDCS to the right dorsolateral prefrontal cortex and Cathode to the left OFC (2 mA, 20 minutes, 10 sessions). In the active group, current stimulations were gradually ramped up to 2 mA (in 30 seconds) intensity for 20 minutes, once a day, for 10 days. For sham stimulation, the procedure was identical, except that the current was gradually ramped up to 2mA and rapidly down to zero (in 30 seconds), thus leading to the same initial sensations of tDCS.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT05622552
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Currently open trials in the same condition.
- NCT06426134 — Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05622552 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dongbin Lyu
- Last refreshed: 18 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05622552.
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