What side effects are associated with this type of intervention?

Transcranial direct-current stimulation (tDCS) is generally well-tolerated, with common side effects including mild tingling, itching, or redness at the site of electrode placement. Other neuromodulation techniques like transcranial magnetic stimulation (TMS) may cause headaches, scalp discomfort, or, rarely, seizures. Noninvasive vagus nerve stimulation (nVNS) can lead to mild side effects such as a warm sensation, tingling, or muscle spasms. Overall, these treatments are considered safe with mostly mild and transient side effects.

What prior FDA approvals exist?

The FDA has approved several neuromodulation techniques for the treatment of various psychiatric conditions, though specific approvals for anhedonia are less clear. Transcranial magnetic stimulation (TMS) is FDA-approved for major depressive disorder and has shown efficacy in modulating neural activity in reward-related brain circuitry, which is relevant to anhedonia. While tDCS is being studied for its potential to engage reward-related brain circuits, it has not yet received FDA approval specifically for anhedonia. Other related treatments, such as vagus nerve stimulation (VNS) and deep brain stimulation (DBS), have FDA approval for treatment-resistant depression and obsessive-compulsive disorder, respectively, but their use in anhedonia remains investigational.

What other types of research exist?

Promising alternatives to tDCS for treating anhedonia include: 1) Transcranial Magnetic Stimulation (TMS), which has shown significant efficacy in reducing migraine pain and may be useful for patients who do not respond to first-line therapies. 2) Noninvasive Vagus Nerve Stimulation (nVNS), which has demonstrated benefits in acute migraine treatment and could be considered for its neuromodulatory effects. 3) Remote Electrical Neuromodulation (REN), which has been effective in reducing acute migraine pain and is controlled via a smartphone. 4) Transcutaneous Supraorbital Nerve Stimulation, which has shown a significant reduction in pain intensity in migraine patients and may offer benefits for anhedonia. These alternatives are noninvasive and have shown promising results in clinical trials.

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Procedure

tDCS for Bipolar Disorder

N/A

Recruiting

Led By Jair C Soares, MD,PhD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

diagnosis of Bipolar Disorder and clinically significant anhedonia

Diagnosis of Bipolar Disorder and clinically significant anhedonia

Must not have

Any severe, life-threatening non-psychiatric medical condition

Previous neurological conditions (epilepsy, traumatic brain injury, stroke, etc)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks

Summary

This trial is testing whether a gentle electrical stimulation of the brain can help people who struggle to feel pleasure. The treatment targets specific brain pathways involved in reward and pleasure. Researchers want to see if this method can improve symptoms by activating these pathways.

Who is the study for?

This trial is for individuals with Bipolar Disorder who experience significant anhedonia (loss of pleasure) and mild depression symptoms. It's not suitable for those with recent substance abuse, personality disorders that affect participation, previous neurological conditions, severe medical issues, metal in the head, or if they're acutely suicidal or severely agitated.

What is being tested?

The study tests transcranial direct-current stimulation (tDCS), a non-invasive brain stimulation technique. Participants will receive either active tDCS or a sham (placebo) treatment to see if it affects brain circuits related to reward and improves feelings of pleasure.

What are the potential side effects?

tDCS may cause minor side effects like itching, tingling, or discomfort at the electrode site on the scalp. Some people might feel fatigue or headache after treatment. Serious side effects are rare when protocols are followed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Bipolar Disorder and experience a significant loss of pleasure in most activities.

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I have been diagnosed with Bipolar Disorder and experience a significant loss of pleasure in most activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe, life-threatening conditions unrelated to mental health.

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I have had a neurological condition like epilepsy, stroke, or brain injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

change in the fractional anisotropy of the uncinate fasciculus

Secondary study objectives

change in symptoms of anticipatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS)

change in symptoms of consummatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS)

changes in symptoms of anhedonia as assessed by the Snaith-Hamilton Pleasure Scale modified for clinical administration (SHAPS-C)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: active tDCSExperimental Treatment1 Intervention

Group II: sham tDCSPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

active tDCS

2018

N/A

~790

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcranial Direct-Current Stimulation (tDCS) is a neuromodulation technique that involves applying a low electrical current to the scalp to modulate neural activity. This treatment targets the reward-related brain circuitry, particularly the uncinate fasciculus tract connecting the orbitofrontal cortex and nucleus accumbens. By enhancing the connectivity and activity within these regions, tDCS aims to alleviate symptoms of anhedonia, which is characterized by a diminished ability to experience pleasure. This modulation is crucial for anhedonia patients as it directly addresses the neural underpinnings of their condition, potentially restoring normal reward processing and improving their overall quality of life.