Effect of tDCS Combined With Pharmacological Treatments for Bipolar Mania

NCT05622552 | Unknown

• 1 other identifier: 2021-YJ12
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Manic Episode

Keywords

manic episode; Transcranial direct current stimulation; tDCS; Functional near-infrared spectroscopy; fNIRS

Outcome Measures

Primary Outcomes (1)

• the reduction in YMRS after two weeks of study

  Young Manic Rating Scale (YMRS), as the most widely used assessment tool for severity of manic symptoms in bipolar patients. We used it to assess the symptoms of mania in subjects and calculated the reduction from the scores before and after 2 weeks of treatment. The response was defined as \>50% reduction in YMRS after two weeks of study.

  two weeks of study

Secondary Outcomes (7)

• the scale of MADRS

  each visit of study in 8 weeks

• the scale of QIDS-16

  each visit of study in 8 weeks

• the scale of ASRM

  each visit of study in 8 weeks

• the scale of WCST

  each visit of study in 8 weeks

• the scale of Stroop Color Word Test

  each visit of study in 8 weeks

Study Arms (2)

active group

ACTIVE COMPARATOR

tDCS stimulation, which was performed once a day sessions of active anodal tDCS to the right dorsolateral prefrontal cortex and cathode to the left OFC (2 mA, 20 minutes, 10 sessions over 2 weeks). 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.

Device: active group of tDCS

sham group

SHAM COMPARATOR

tDCS stimulation, which was performed once a day sessions of sham anodal tDCS to the right dorsolateral prefrontal cortex and cathode to the left OFC (2 mA, 20 minutes, 10 sessions over 2 weeks). 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.

Device: sham group of tDCS

Interventions

active group of tDCS DEVICE

Transcranial direct current stimulation(tDCS) is a neurostimulation that has aroused concern in psychiatry. As a non-invasive brain modulation that delivered a weak direct current (0.5-2 mA) via two scalp electrodes (an anode and a cathode) overlying targeted cortical areas. It can produce polarity-dependent effects, like inducing functional changes in resting membrane potential and cerebral blood flow. Specifically, a depolarization of the neurons membranes by anodal stimulation and thus invokes an increase of the spontaneous neuronal firing rate, whereas cathodal stimulation induces neuronal hyperpolarization. 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.

active group

sham group of tDCS DEVICE

Transcranial direct current stimulation(tDCS) is a neurostimulation that has aroused concern in psychiatry. As a non-invasive brain modulation that delivered a weak direct current (0.5-2 mA) via two scalp electrodes (an anode and a cathode) overlying targeted cortical areas. It can produce polarity-dependent effects, like inducing functional changes in resting membrane potential and cerebral blood flow. Specifically, a depolarization of the neurons membranes by anodal stimulation and thus invokes an increase of the spontaneous neuronal firing rate, whereas cathodal stimulation induces neuronal hyperpolarization. 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.

sham group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Manic episode in patient with bipolar disorder, as assessed by the Structured Clinical Interview for DSM-IV, Axis I Disorders, Patient Version (SCID-I/P).
• \. Young Mania Rating Scale (YMRS) score above or equal 13.
• \. Patients of both genders between 18 and 65 years of age (when obtaining informed consent) ,right-handed.
• \. Junior high school education and above, with understanding of the content of the study.
• \. Written, informed and competent consent was obtained before participation in the study.
• \. The regimens and dosages of mood stabilizers and atypical antipsychotics remained stable from the start of tDCS to the completion of 10 tDCS sessions. One mood stabilizer and/or one atypical antipsychotics could be administered, and no new or discontinued drugs were added
• \. Did not receive other trials of neurostimulation treatments (include tCS, rTMS, MECT.etc) and psychotherapies 1 month before tDCS treatment to 2 weeks after the end of treatment.
• \. Benzodiazepines and antidepressants were not used from 1 month before tDCS treatment to 2 weeks after the end of treatment.

You may not qualify if:

• \. Laboratory abnormalities that are judged to be clinically significant and that clinicians consider to affect the efficacy of the trial or the safety of the subjects.
• \. With severe or unstable diseases, including: Patients with neurological diseases (delirium, dementia, stroke, epilepsy, migraine, high intracranial pressure, craniocerebral surgery, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), apnea syndrome, malignant tumors, immunocompromised subjects, acute or chronic liver and kidney failure, cirrhosis or active liver disease, Or blood glucose higher than 12mmol/L.
• Alcohol or drug dependence within 6 months before the trial.
• Pregnant and lactating women. Male and female subjects who are not using effective contraception or who plan to become pregnant within 3 months of starting the trial.
• Family history of epilepsy (within three generations).
• History of head trauma or craniocerebral surgery such as open wound or skull repair.
• Other conditions that were not appropriate for participation in the clinical trial.

Sponsors & Collaborators

• Dongbin Lyu: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Mania

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dongbin Lyu, MBBS

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongbin Lyu, MBBS

CONTACT

+86 64387250; shuiysuper@foxmail.com

Weichieh Yang, MBBS

CONTACT

+8613701635337

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The random numbers generated by the computer software and corresponding to the serial number were assigned to the DLPFC 2mA once/day group and the sham stimulation once/day group, and the random number sequence was recorded. Patients eligible for inclusion were randomly assigned to different treatment groups in a 1:1 ratio. Those who determine the random number grouping shall not participate in the inclusion of subjects. The implementation of randomization and the verification and storage of grouping information were operated by specialists. Study operators, clinical evaluators, and patients were not aware of their intervention grouping. In case of urgent adverse events, blinding should be undone, and the relationship between adverse events and treatment should be studied and reported to the ethics committee.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 18, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

CN (1)