MRI Study of High Definition Transcranial Electrical Stimulation in Chronic Tinnitus (MRI HDtES-T)

(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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS)?

Research shows that tDCS has been studied for various conditions like depression, schizophrenia, and pain syndromes, with many studies reporting positive results. Although there is variability in how people respond, the treatment is generally considered safe with mild side effects like headaches. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with studies showing no serious adverse effects in over 33,200 sessions. Common mild side effects include itching, tingling, and headaches, but these are not significantly different from those experienced with a placebo. ^{6 7 8 9 10}

How is transcranial direct current stimulation (tDCS) different from other treatments?

Transcranial direct current stimulation (tDCS) is unique because it is a non-invasive treatment that uses small electrical currents to stimulate specific areas of the brain, which can help modulate sensory and pain perception. Unlike many other treatments, it does not involve medication and can be used to target specific brain regions without surgery. ^{4 11 12 13 14}

What is the purpose of this trial?

This trial is testing a gentle brain stimulation technique called HDtES on adults who have chronic ringing in their ears. The treatment uses small electrodes to send a mild electrical current through the scalp, aiming to change brain activity and connections. Researchers will measure changes in brain function and tinnitus symptoms over time. High-definition transcranial direct current stimulation (HD-tDCS) has been explored in previous studies for its potential to modulate brain activity and improve auditory processing in tinnitus patients.

Eligibility Criteria

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

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

Treatment Details

Interventions

• Transcranial Direct Current Stimulation

Participant Groups

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+

Findings from Research

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]

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]

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]

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, 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Inter- and Intra-individual Variability in Response to Transcranial Direct Current Stimulation (tDCS) at Varying Current Intensities. [2018]

2. France pubmed.ncbi.nlm.nih.gov

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

Notes on Human Trials of Transcranial Direct Current Stimulation between 1960 and 1998. [2022]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, Blinding Efficacy and Behavioural Effects of a Novel MRI-Compatible, High-Definition tDCS Set-Up. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Beta-frequency EEG activity increased during transcranial direct current stimulation. [2014]

12. United States pubmed.ncbi.nlm.nih.gov

Evaluation of sham transcranial direct current stimulation for randomized, placebo-controlled clinical trials. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

MRI study of human brain exposed to weak direct current stimulation of the frontal cortex. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Modulatory effects of anodal transcranial direct current stimulation on perception and pain thresholds in healthy volunteers. [2015]