Treatment of Chronic Bothersome Tinnitus Using Cognitive Training and D-cycloserine

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: Sedatives, Hypnotics, Narcotics, Opiates

Disqualifiers: Neurological conditions, Psychiatric disorders, Others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 5 weeks

37 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not take any medications that are contraindicated (not recommended) with d-cycloserine or any medications that may affect cognition, such as sedatives, hypnotics, narcotics, and opiates. If you are on such medications, you may need to stop them to participate.

What data supports the effectiveness of this treatment?

Research shows that computerized cognitive training can help improve attention and mood in people with cognitive disorders and depression. It is especially effective when combined with other therapies, and patients with more severe cognitive issues tend to benefit the most. ^{1 2 3 4 5}

Is computerized cognitive training safe for humans?

Computerized cognitive training is generally considered safe for humans. Studies have reported no serious negative effects, though some participants experienced mild issues like mental fatigue, headache, and eye irritation. ^{1 5 6 7 8}

How is Cognitive Training different from other treatments for cognitive disorders?

Cognitive Training is unique because it uses computer-based exercises to improve cognitive function, making it an ideal tool for enhancing attention and reaction times. Unlike traditional therapies, it can be tailored and integrated into a broader therapeutic framework, providing a flexible and engaging way to achieve necessary therapeutic intensity. ^{1 7 9 10 11}

What is the purpose of this trial?

This trial is testing whether a medication called d-cycloserine, combined with a computer program to improve memory and attention, can help people with chronic tinnitus. The medication may enhance the brain's ability to learn and adapt, which could reduce tinnitus symptoms and improve memory and focus. Participants will receive either the medication or a similar treatment along with the computer program. D-cycloserine is being studied to see if it can help with learning and memory for tinnitus treatment.

Research Team

Jay F Piccirillo, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

Participants must be between the ages of 35 and 65.

Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus for at least a duration of 6 consecutive months.

Participants must have bothersome tinnitus as defined by a THI ≥ 30.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive training with either d-cycloserine or placebo for 5 weeks

5 weeks

2 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cognitive Training
• D-cycloserine

Participant Groups

Group I: d-cycloserine Active Control 1 Intervention

d-cycloserine 250 mg two days per week one hour prior to(cognitive training)

Group II: Placebo Placebo Group 1 Intervention

Placebo pill two days per week 1 hour prior to cognitive training

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Findings from Research

Computer-assisted cognitive training has been shown to be an effective tool in neurological rehabilitation, particularly for patients with attention deficits, as it allows for precise stimulus representation and reaction time measures.

This type of training is most beneficial when integrated into a comprehensive therapeutic framework, enhancing the overall rehabilitation process and ensuring sufficient therapeutic intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Computer-assisted neuropsychological training in neurological rehabilitation]. Reuter, BM., Schönle, PW.[2006]

Computerized cognitive training (CCT) using Brain HQ showed significant cognitive improvements in psychiatric rehabilitation clients, with an average increase of 4.4 points in BACS t-scores after about 17 days of training.

Higher engagement in training (measured by levels completed per day) was positively correlated with cognitive gains, suggesting that monitoring engagement can help identify patients who may need additional support to benefit from CCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training engagement, baseline cognitive functioning, and cognitive gains with computerized cognitive training: A cross-diagnostic study. Harvey, PD., Balzer, AM., Kotwicki, RJ.[2020]

In a study involving 46 young adults with mild depressive symptoms, executive functioning and processing speed (EF/PS)-focused computerized cognitive training (CCT) led to greater improvements in those specific cognitive areas compared to verbal ability-focused CCT.

Both types of CCT resulted in significant improvements in mood and everyday functioning, but the EF/PS group achieved similar mood benefits with only half the training time, suggesting that the content of CCT may not be as crucial as the engagement in the training itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in young adults with depressive symptoms: Effects on mood, cognition, and everyday functioning. Motter, JN., Grinberg, A., Lieberman, DH., et al.[2019]

The RehaCom computerized cognitive training program significantly improved attention and memory functions in 50 brain injury patients after 60 training sessions, with all patients showing enhanced performance in the targeted areas.

The program was well-tolerated, with no reported negative effects such as mental fatigue, headache, or eye irritation, indicating its safety for use in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. Fernández, E., Bringas, ML., Salazar, S., et al.[2022]

This study aims to systematically review and analyze the efficacy of computerized cognitive training (CCT) in improving cognitive performance in adults with depression, focusing on randomized controlled trials.

The research will explore how CCT affects not only cognitive outcomes but also mood and daily functioning, making it the first comprehensive analysis of its kind in this specific clinical population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in people with depression: a protocol for a systematic review and meta-analysis. Lampit, A., Launder, NH., Minkov, R., et al.[2022]

The trial involved 18 adolescents with ADHD over a 7-week period, comparing computerized cognitive exercises from Scientific Brain Training (SBT) to the game Tetris as an active placebo.

While no significant differences were found between the two groups, SBT showed a significant improvement in sustained attention, and Tetris improved working memory, indicating that both interventions may have beneficial effects on cognitive functions in adolescents with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind randomized pilot trial comparing computerized cognitive exercises to Tetris in adolescents with attention-deficit/hyperactivity disorder. Bikic, A., Christensen, TØ., Leckman, JF., et al.[2018]

Home-based Computerized Cognitive Training (CCT) tailored to individual needs significantly improved cognitive functions such as memory and learning in older adults with mild cognitive impairment (MCI) and mood-related neuropsychiatric symptoms (MrNPS) over an 8-12 week period.

Participants in the CCT group not only showed enhanced cognitive performance but also reported improved mood and reduced caregiver burden compared to those in the active control group, indicating broader benefits beyond just cognitive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored and Adaptive Computerized Cognitive Training in Older Adults at Risk for Dementia: A Randomized Controlled Trial. Bahar-Fuchs, A., Webb, S., Bartsch, L., et al.[2022]

A study involving 60 patients with mild cognitive impairment and mild Alzheimer's disease found that adding a computer-based cognitive training (CBCT) program to traditional cognitive training (TCT) significantly reduced anxiety symptoms and improved decision-making after 12 months.

While the CBCT + TCT group showed benefits in anxiety and decision-making, there were no significant changes in basic cognitive functions, suggesting that patients already receiving TCT may have reached a performance ceiling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an adjunctive computer-based cognitive training program in amnestic mild cognitive impairment and Alzheimer's disease: a single-blind, randomized clinical trial. Gaitán, A., Garolera, M., Cerulla, N., et al.[2022]

Thirty patients with chronic cognitive deficits post-stroke participated in a study comparing two types of Computerized Cognitive Training (CCT) over 6 weeks, showing that both types led to improvements in cognitive functioning.

Group A, which received customized CCT, reported fewer subjective complaints, while Group B, which received non-customized CCT, showed better performance-based improvements, indicating that both tailored and standard CCT can be beneficial for cognitive recovery in chronic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional improvement in chronic stroke patients when following a supervised home-based computerized cognitive training. Gil-Pagés, M., Solana, J., Sánchez-Carrión, R., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Computer-assisted neuropsychological training in neurological rehabilitation]. [2006]

2. Germany pubmed.ncbi.nlm.nih.gov

[Computer assisted cognitive training advances mood and psychological wellbeing - a comparison to paper pencil training relating to neuropsychological parameters, mood and cognitions]. [2011]

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

Training engagement, baseline cognitive functioning, and cognitive gains with computerized cognitive training: A cross-diagnostic study. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in young adults with depressive symptoms: Effects on mood, cognition, and everyday functioning. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Developing cognitive-emotional training exercises as interventions for mood and anxiety disorders. [2022]

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

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. [2022]

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

Computerized cognitive training in people with depression: a protocol for a systematic review and meta-analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A double-blind randomized pilot trial comparing computerized cognitive exercises to Tetris in adolescents with attention-deficit/hyperactivity disorder. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Tailored and Adaptive Computerized Cognitive Training in Older Adults at Risk for Dementia: A Randomized Controlled Trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy of an adjunctive computer-based cognitive training program in amnestic mild cognitive impairment and Alzheimer's disease: a single-blind, randomized clinical trial. [2022]

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

Functional improvement in chronic stroke patients when following a supervised home-based computerized cognitive training. [2023]