Transcranial Electrical Stimulation for Tinnitus

(MRI HDtES-T Trial)

Overseen By Amber Leaver

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Decongestants, Antihistamines, Benzodiazepines, Antipsychotics

Disqualifiers: Severe mood disorders, Neurological disorders, Alcohol/substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a gentle brain stimulation technique, transcranial direct current stimulation (tDCS), affects brain function in individuals with chronic tinnitus. Tinnitus causes individuals to hear a ringing noise in their ears without any external sound. The study employs a special brain scan, known as fMRI, to observe changes in brain activity. Suitable participants have experienced tinnitus for over a year, notice it most of the time, and have ruled out other medical causes with their doctor. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on tinnitus treatment.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants using medications that can affect brain function, such as decongestants, antihistamines, benzodiazepines, anticonvulsants, or antipsychotics.

What prior data suggests that this neurostimulation technique is safe for adults with chronic subjective tinnitus?

Research has shown that transcranial direct current stimulation (tDCS) is usually safe in human trials. Studies have found that using tDCS for less than 40 minutes at a time with a current of 4 milliamps or less does not cause serious side effects. Most side effects are minor, such as skin irritation. This method involves placing electrodes on the scalp to send a gentle electric current and is under study for various health conditions. Although the FDA has not yet approved tDCS, current evidence suggests it is safe for use in studies like this one. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for chronic tinnitus focus on managing symptoms through sound therapy, cognitive behavioral therapy, or medications like antidepressants. However, the method under study, High Definition Transcranial Electrical Stimulation (HDtES), is unique because it directly targets brain activity with electrical currents to potentially alter the neural circuits involved in tinnitus. This non-invasive technique is exciting because it offers a new way to modulate brain function without the side effects associated with medication, and it holds the promise of providing more rapid relief compared to traditional therapies that often require weeks to months for noticeable improvement. Researchers are hopeful that this approach could lead to a breakthrough in how we understand and treat tinnitus, making it a promising area of exploration.

What evidence suggests that transcranial direct current stimulation (tDCS) is effective for chronic subjective tinnitus?

Research has shown that transcranial direct current stimulation (tDCS) can enhance brain function. Studies have found that tDCS eases anxiety symptoms in conditions like OCD and PTSD. It also lifts mood and improves thinking and memory skills. People with depression reported feeling better after using tDCS, with benefits persisting even after treatment ends. In this trial, participants will receive either active tDCS or a sham treatment. While research continues, these findings suggest that tDCS could be a promising option for managing chronic tinnitus. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

You have the capacity to give informed consent.

You have discussed tinnitus symptoms with clinician to confirm low/no likelihood of physical or neurological origin of tinnitus symptoms (e.g., acoustic neuroma, Meniere's Disease, etc.), confirmed by patient self-report.

Ages between 18 and 75

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive transcranial direct current stimulation (tDCS) for 20 minutes per session over 5 consecutive days

1 week

Follow-up

Participants are monitored for changes in tinnitus symptoms and brain function after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

Group II: Sham Placebo Group 1 Intervention

Transcranial Direct Current Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Depression
• Anxiety

Approved in European Union as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Neurological rehabilitation

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

High-Definition transcranial Direct Current Stimulation (HD-tDCS) at amplitudes up to 4 mA was well tolerated by 292 older adults, with no safety-related adverse events reported and mostly mild sensations experienced during sessions.

The study demonstrated effective blinding for both participants and researchers, indicating that the sham stimulation was convincing, which supports the use of higher amplitudes for potentially greater therapeutic effects in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of high-definition transcranial direct current stimulation among older adults at intensities of up to 4 mA per electrode. El Jamal, C., Harrie, A., Rahman-Filipiak, A., et al.[2023]

Transcranial direct current stimulation (tDCS) effectively increases beta-frequency power in the brain, indicating a readiness for improved cognitive functioning, as observed in a study with 10 healthy participants.

This study is significant as it is the first to simultaneously apply tDCS while recording EEG, providing insights into the dynamic changes in brain activity during stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beta-frequency EEG activity increased during transcranial direct current stimulation. Song, M., Shin, Y., Yun, K.[2014]

Transcranial direct current stimulation (tDCS) is a noninvasive technique that can significantly alter brain functions and has been studied in 340 clinical articles for various conditions, including depression, pain syndromes, and neurodegenerative diseases.

The review provides a comprehensive overview of the clinical applications of tDCS, detailing factors such as study design, sample size, and stimulation parameters, which can help guide future research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive database of published tDCS clinical trials (2005-2016). Lefaucheur, JP.[2022]

The novel high-definition transcranial direct current stimulation (HD-tDCS) setup was found to be safe and well-tolerated, with fewer adverse effects compared to conventional tDCS, based on a study involving 60 healthy participants.

HD-tDCS significantly improved cognitive performance on a visual task, indicating its potential for more effective neural modulation, while also being compatible with simultaneous fMRI without causing significant heating or image quality issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, Blinding Efficacy and Behavioural Effects of a Novel MRI-Compatible, High-Definition tDCS Set-Up. Gbadeyan, O., Steinhauser, M., McMahon, K., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

A review of 15 studies on transcranial direct current stimulation (tDCS) before 1998 found that most trials (about 83%) focused on treating psychiatric conditions like depression and schizophrenia, with 12 out of 15 studies showing positive outcomes.

While the stimulation intensities used in older studies were lower than modern standards, the longer session durations and higher current densities suggest that these factors may have contributed to the encouraging results and mild side effects reported, such as headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notes on Human Trials of Transcranial Direct Current Stimulation between 1960 and 1998. Esmaeilpour, Z., Schestatsky, P., Bikson, M., et al.[2022]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11345433/

Immediate and long-term efficacy of transcranial direct current ...

The results of meta-analysis suggested that tDCS reduced the severity of general anxiety symptoms in OCD, PTSD and ADs, with a high effect size ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2324242625000129

Comparison of the efficacy of high-definition transcranial ...

All groups demonstrated significant improvement in depressive symptoms and cognitive function. The rTMS group exhibited a significantly greater decrease in ...

3.

nature.com

nature.com/articles/s41591-024-03305-y

Home-based transcranial direct current stimulation ...

In summary, a 10-week course of home-based active tDCS was associated with greater improvements in depressive symptoms, clinical response and ...

4.

thelancet.com

thelancet.com/journals/lancet/article/PIIS0140-6736(24)00634-2/fulltext

How effective is transcranial direct current stimulation?

The authors conducted a 6-week, triple-blind, randomised sham-controlled, multicentre trial in patients with MDD to assess the efficacy of tDCS ...

5.

frontiersin.org

frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2025.1495492/full

Efficacy of transcranial direct current stimulation on ...

The improvement of executive function, memory, attention, language, quality of life, and depression with tDCS were the secondary outcome ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ...

To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 mA, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or ...

7.

nature.com

nature.com/articles/s41380-024-02624-3

Effects and safety of transcranial direct current stimulation ...

Effects and safety of transcranial direct current stimulation on multiple health outcomes: an umbrella review of randomized clinical trials.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6123849/

Adverse events of tDCS and tACS: A review - PubMed Central

No serious adverse effects have been reported in experiments using either tDCS or tACS. Persistent adverse effects of tDCS are mainly skin problems; for tACS, ...

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S2590109523000447

Feasibility and Safety of Sequential Transcranial ...

This study provides preliminary evidence about the feasibility, safety, and challenges to combine PT and tDCS in very frail older adults.

10.

neuromodec.org

neuromodec.org/what-is-transcranial-direct-current-stimulation-tdcs/

What is transcranial Direct-Current Stimulation (tDCS)?

Is tDCS FDA approved? ... tDCS is currently not FDA approved. That means that the USA FDA has not evaluated and approved a “marketing” application from a company.