Prism Adaptation + TENS for Unilateral Spatial Neglect

MP
RM
Overseen ByRachelle M Janning, OTD, MS, OTR/L
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Kettering Health Network
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS) improves attention to one side of the body more effectively than PAT alone for stroke survivors. PAT involves wearing special goggles to help the brain adapt, while TENS uses gentle electrical pulses to increase awareness in the affected arm. The trial seeks stroke survivors who struggle with attention to one side and have at least mild symptoms on a neglect scale. Participants should not have had more than two strokes, a history of seizures, certain mental illnesses, or specific medical devices like pacemakers. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance stroke recovery therapies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Prism Adaptation Training with TENS is safe for stroke patients?

Studies have shown that Prism Adaptation Therapy (PAT) is generally safe and can improve symptoms like neglect and motor control issues after a stroke. Evidence suggests that combining PAT with Transcutaneous Electrical Nerve Stimulation (TENS), which uses gentle electrical currents to stimulate nerves, offers additional benefits. Research indicates that TENS is also well-tolerated, with only minor side effects like skin irritation sometimes reported.

Although specific data on the safety of using PAT and TENS together is limited, each treatment is already used separately without major problems. This suggests that their combined use should also be safe. Prospective participants in a clinical trial involving both treatments may find reassurance in this past evidence regarding their safety.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about combining Prism Adaptation Training (PAT) with Transcutaneous Electrical Nerve Stimulation (TENS) for treating unilateral spatial neglect because it introduces a novel dual-approach. Unlike traditional therapies that typically focus solely on visual or motor rehabilitation, this method enhances sensory awareness by using TENS to stimulate the neglected side, potentially leading to more comprehensive neural adaptation. Additionally, the use of prism goggles shifts the visual field, encouraging the brain to recalibrate its perception and motor responses together, which could offer faster and more effective recovery. This integrated approach might provide significant advantages over existing single-modality treatments, offering new hope for those with this challenging condition.

What evidence suggests that this trial's treatments could be effective for unilateral spatial neglect?

Research has shown that prism adaptation therapy (PAT) can significantly aid individuals with unilateral spatial neglect, a condition affecting attention and movement after a stroke. Studies have found that PAT improves scores on tests measuring this condition, such as the Behavioral Inattention Test. In this trial, one group of participants will receive PAT alone, while another group will receive PAT combined with Transcutaneous Electrical Nerve Stimulation (TENS). Early findings suggest that combining PAT with TENS might enhance these improvements. TENS sends small electrical signals to the neglected side of the body to boost sensory awareness. Although more research is needed to confirm these benefits, initial evidence is promising for enhancing attention and function in stroke survivors.16789

Who Is on the Research Team?

RM

Rachelle M Janning, OTD, MS, OTR/L

Principal Investigator

Kettering Health/Northern Kentucky University

Are You a Good Fit for This Trial?

This trial is for stroke survivors with unilateral spatial neglect, who score at least '1' on the Catherine Bergego Scale and can consent to participate. It's not for those with multiple strokes, seizures, severe mental illness like schizophrenia, cancer in the affected arm, or if they have a pacemaker/defibrillator or cannot feel their affected arm.

Inclusion Criteria

I have been diagnosed with a stroke.
I scored 1 or higher on the Catherine Bergego Scale.
I understand and can make decisions about my health care.

Exclusion Criteria

I have a seizure disorder.
Individuals with pacemakers and defibrillators
My cancer is located in my upper arm or shoulder area.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Prism Adaptation Training (PAT) with or without Transcutaneous Electrical Nerve Stimulation (TENS) to address unilateral spatial neglect (USN)

8-12 weeks
Weekly therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Prism Adaptation Training
  • Prism Adaptation Training with TENS
Trial Overview The study compares two treatments: Prism Adaptation Therapy (PAT) alone versus PAT combined with Transcutaneous Electrical Nerve Stimulation (TENS). The goal is to see which treatment better helps patients pay attention to the neglected side of their body after a stroke.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: PAT + TENS treatmentExperimental Treatment1 Intervention
Group II: PAT onlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kettering Health Network

Lead Sponsor

Trials
20
Recruited
1,700+

Citations

Comparing Prism Adaptation Training With and Without ...This study aims to find out if doing two treatments together-Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS)-will help ...
Prism adaptation and spatial neglect: the need for dose- ...We present preliminary data suggesting that four to six sessions of prism treatment may induce a large treatment effect, maintained three to four weeks post- ...
Effectiveness of Prism Adaptation in Neglect RehabilitationThis study was conducted to investigate the effectiveness on neglect recovery of a 2-week treatment based on prism adaptation (PA)
Effects of Prism Adaptation for Unilateral Spatial Neglect...According to meta-analysis results, prism adaptation group scored significantly higher than control group in improving Behavioral Inattention Test (mean ...
Prism adaptation combined with eye movement training for ...We will explore a new treatment option that combines prism adaptation (PA) with eye movement training (EMT) for the treatment of USN after stroke.
Prism adaptation combined with eye movement training for ...Unilateral spatial neglect is a complex neurological syndrome with a high prevalence and adverse effects. In this study, we design a random and comparison ...
Prism Adaptation + TENS for Unilateral Spatial NeglectThis study aims to find out if doing two treatments together-Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS)-will help ...
Virtual reality rehabilitation for unilateral spatial neglectResults showed improvement in motor and cognitive performance after training and almost complete resolution of neglect symptoms, especially with the S-IVT ...
Effect of Prism Adaptation Therapy on the Activities of Daily ...In this study, gaze orientation and personal belongings, among the 10 items of the CBS, were improved in the prism group compared with the control group.
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