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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 belowSelect...
I have been diagnosed with Bipolar Disorder and experience a significant loss of pleasure in most activities.
Select...
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:Select...
I do not have any severe, life-threatening conditions unrelated to mental health.
Select...
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
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
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.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
946 Previous Clinical Trials
344,540 Total Patients Enrolled
2 Trials studying Anhedonia
125 Patients Enrolled for Anhedonia
Milken InstituteOTHER
7 Previous Clinical Trials
229 Total Patients Enrolled
Jair C Soares, MD,PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a personality disorder that may make it difficult for you to take part in the study.You have metal plates in your head that can't be used with the treatment.I experience mild feelings of sadness or hopelessness.I have been diagnosed with Bipolar Disorder and experience a significant loss of pleasure in most activities.I experience mild depression symptoms.You have a history of using drugs or being dependent on them, except for alcohol or nicotine.You are currently feeling very suicidal or extremely agitated.I do not have any severe, life-threatening conditions unrelated to mental health.I have been diagnosed with Bipolar Disorder and experience a significant loss of pleasure in most activities.I have had a neurological condition like epilepsy, stroke, or brain injury.
Research Study Groups:
This trial has the following groups:- Group 1: active tDCS
- Group 2: sham tDCS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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