HD-tDCS for Lewy Body Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
2101 Commonwealth Blvd, Suite D (University of Michigan), Ann Arbor, MI
Lewy Body Disease+5 More
HD-tDCS - Device
Eligibility
18+
All Sexes
Eligible conditions
Lewy Body Disease

Study Summary

This study is evaluating whether a non-invasive way of stimulating the brain may help reduce fluctuations in alertness for individuals with Lewy body dementia.

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Eligible Conditions

  • Lewy Body Disease
  • Problem Behavior
  • Alzheimer Disease
  • Dementia
  • Lewy Body Variant of Alzheimer Disease
  • Lewy Body Dementia With Behavioral Disturbance (Disorder)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether HD-tDCS will improve 1 primary outcome and 1 secondary outcome in patients with Lewy Body Disease. Measurement will happen over the course of Baseline and Post-Testing (3-4 weeks).

Week 4
Change from Baseline Resting State fMRI
Change from Baseline on Dementia Cognitive Fluctuations Scale

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Experimental: HD-tDCS

This trial requires 18 total participants across 2 different treatment groups

This trial involves 2 different treatments. HD-tDCS is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental: HD-tDCS
Device
Maximum 4 milliAmp (mA) per channel of HD-tDCS treatment for 20 minutes, for 10 sessions. Total mA dose determined by individualized computational models.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HD-tDCS
2015
Completed Early Phase 1
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and post-testing (3-4 weeks)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline and post-testing (3-4 weeks) for reporting.

Who is running the study

Principal Investigator
B. H.
Prof. Benjamin Hampstead, PhD
University of Michigan

Closest Location

2101 Commonwealth Blvd, Suite D (University of Michigan) - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lewy Body Disease or one of the other 5 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
LBD patients (DLB or PDD) who have cognitive fluctuations and who are on stable doses of cholinesterase inhibitors (i.e., at least 4 weeks) will be recruited to participate in this study.
DLB patients will meet the Fourth consensus report of the DLB Consortium inclusion criteria for probable DLB.
Subjects will be identified according to the following recognized DLB features: spontaneous parkinsonian motor signs, fluctuating attention and concentration, recurrent well-formed visual hallucinations, presence of REM behavioral sleep disturbance, anosmia/hyposmia,or autonomic dysfunction.
PDD patients will meet the criteria by Emre et al. (Cognitive deficits in at least two of four of the following cognitive domains: Impaired attention, impaired executive functions, impairment in visuo-spatial functions, impaired free recall memory typically improved with cuing. Must also meet criteria for at least one behavioral symptom: apathy, depressed or anxious mood, hallucinations, delusions, excessive daytime sleepiness). Lack of behavioral symptoms does not exclude the diagnosis. Must also have none of Group III features present: (1) Co-existance of any other abnormality which might cause impairment, but judged not to be the cause of dementia. (2) Time interval between development of motor and cognitive symptoms not known. Must also have none of Group IV symptoms present: (1) Cognitive and behavioral symptoms appear solely in the context of other conditions such as acute confusion caused by systemic diseases or abnormalities, drug intoxication, or major depression according to DSM IV. (2) Features compatible with Probable Vascular Dementia criteria accordingly to NINDS-AIREN.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is hd-tdcs safe for people?

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Although the authors are aware of the limited evidence, they advise the cautious use of Tdcs for people in whom [HbA1c] is >9% and whose cognitive functioning is acceptable.

Unverified Answer

Can lewy body disease be cured?

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LBD appears to be benign lesions as in the case of multiple myeloma. This benign lesion may be cured by total excision of the lesion using a standard laser excision procedure and by using a simple and inexpensive excision technique. Thus, the authors have not concluded it is curable in the sense of a standard treatment for the disease.

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What causes lewy body disease?

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The pathogenesis of the lewy body disease process and its diagnostic distinction from dementia with Lewy bodies has also not been elucidated. LBD may represent a spectrum of pathology within the dementia spectrum, or may represent a distinct and unrelated entity.

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What are the signs of lewy body disease?

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Although the signs of LBD are not specific, they can serve as complementary information about the diagnosis. Because of its early onset, LBD can lead to dementia (mental deterioration), even without the presence of a diagnosis of dementia, which can be confirmed only by brain pathology.

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How many people get lewy body disease a year in the United States?

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Since the first identification of cases in the United States, the prevalence of the disease has been debated. This is of public health and interest considering the possibility that lewy body disease may be a surrogate marker for early stages of prion disease. Currently, we are unable to estimate the prevalence of a disorder with a disease of uncertain cause that is currently considered rare. We estimate that the prevalence of this disorder is approximately 1.27 cases per 100,000 in the US. For comparison, there are approximately 18 cases per 100,000 cases of Alzheimer's disease, and 3 cases per 100,000 cases of ALS.

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What is lewy body disease?

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LBPD is an inherited neurodegenerative disease characterized by the progressive loss of neurons and gliosis in the central nervous system. LBPD affects various neuron populations in the brain, but particularly in the hippocampus, cerebellum, basal ganglia, and cerebellar vermis. The most common clinical feature is dementia with a gradual onset; other features include muscle weakness, sleep disturbance, hallucinations, and dysphoria. These features should raise the suspicion of LEBPD in patients with a history of dementia or unexplained deterioration of cognition.

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What are common treatments for lewy body disease?

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Many treatment and follow-up options exist for LD/PLD. However, given the lack of evidence in patient treatment, and a lack of evidence-based management guidelines for LD, it is not possible to recommend one treatment over others.

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Have there been any new discoveries for treating lewy body disease?

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Since the discovery of the genetic mutation that causes lewy body disease in the early 1980s, several discoveries have been made and are currently being studied within the research community in hopes of finding a more effective treatment for the disease which still does not have a cure yet. Currently, there are several investigational therapies that are underway that target the gene, protein and/or mitochondria functionality in order for treatment options to be found. The best treatment option for lewy body disease will still have to be discovered but there are some promising developments happening in the research community.

Unverified Answer

What is the latest research for lewy body disease?

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Levadopa use alone was sufficient for a considerable proportion of the patients. More research is needed to define the best treatment for patients with LBD and LBD/DLB.

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How does hd-tdcs work?

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[Hd-tdcs is safe and effective for treating patients with diffuse and multifocal form of lewy body disease. This therapy seems to be effective in controlling symptoms even in the advanced phases of disease; the response is independent from the baseline parameters of disease duration, age and disease progression. Findings from a recent study of this pilot study have pave the way for the larger-scale clinical studies on HD-tdcs efficiency in the prevention and treatment of this disease.

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Have there been other clinical trials involving hd-tdcs?

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hd-tdcs therapy could be an interesting and valid treatment option, as well it is safe and effective. A large randomized double-blind placebo-controlled clinical trial of hd-tdcs would be ideal because [hd-tdcs therapy in combination with baclofen, in comparison to baclofen alone, shows a synergistic effect on spasticity in patients with spastic CP] and because only one double-blind placebo-controlled placebo randomized trial has been conducted.

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What is the primary cause of lewy body disease?

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Even if the lewy bodies are found only in 1 of the 3 major organs, they may still be caused by a systemic disease. The primary cause of the disease should therefore be studied and treated.

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