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Procedure

Deep Brain Stimulation for Movement Disorders

N/A

Recruiting

Led By Kareem A Zaghloul, M.D.

Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be 18 years of age or older.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is studying how deep brain stimulation surgery affects people with movement disorders.

Who is the study for?

This trial is for adults over 18 with movement disorders like Parkinson's disease, essential tremor, and dystonia that aren't well-managed by medication. Candidates must be able to understand and agree to the study's procedures.Check my eligibility

What is being tested?

The trial studies Deep Brain Stimulation (DBS) surgery effects on movement disorders. It involves implanting a device to stimulate brain areas linked to movement and recording nerve cell function during surgery.See study design

What are the potential side effects?

Potential side effects of DBS may include headache, infection at the site of surgery or stimulator, speech problems, balance issues, numbness or tingling sensations, and unwanted mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

physiology and efficacy of DBS surgery for movement disorders

Side effects data

From 2018 Phase 2 trial • 53 Patients • NCT01221948

23%

Fall

15%

Depression

Hand fracture

Restless legs syndrome

Apathy

Head injury

Dyspepsia

Back pain

Speech disorder

Skeletal injury

Tremor

Gait disturbance

Dystonia

Paraesthesia

Influenza

Urinary tract infection

Pain in extremity

Diabetes mellitus

Intervertebral disc protrusion

Spinal osteoarthritis

Fluid retention

Postoperative wound infection

Osteoarthritis

Macular degeneration

Hypoaesthesia

Ingrowing nail

Respiratory depression

Parkinson's disease

Akinesia

Productive cough

Device migration

Syncope

Diplopia

Skin laceration

Joint sprain

Rib fracture

Drug withdrawal syndrome

Alcohol poisoning

Contusion

Cerebral microangiopathy

Dysarthria

Memory impairment

Movement disorder

Monarthritis

Neck pain

Adverse drug reaction

Cyst

Implant site haematoma

Oedema peripheral

Pyrexia

Pleural effusion

Nerve root lesion

Anxiety

Cough

Fibula fracture

Thermal burn

Sciatica

Anger

Bursitis

Cystitis

Helicobacter gastritis

Implant site infection

Localised infection

Pneumonia

Staphylococcal infection

Confusional state

Depressed mood

Hallucination, auditory

Impulse-control disorder

Insomnia

Panic attack

Rapid eye movements sleep abnormal

Bronchitis

Ear infection

Incision site infection

Arthralgia

Axillary pain

Folate deficiency

Hypertension

Hypotension

Thrombophlebitis

Laboratory test abnormal

Weight increased

Pericardial effusion

Seborrhoeic keratosis

Urinary incontinence

100%

80%

60%

40%

20%

Study treatment Arm

Deep Brain Stimulation

Trial Design

1Treatment groups

Experimental Treatment

Group I: treatment armExperimental Treatment1 Intervention

patients with Parkinson's Disease, dysonia, and essential tremor

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deep Brain Stimulation

2011

Completed Phase 2

~700

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor

1,340 Previous Clinical Trials

649,159 Total Patients Enrolled

Kareem A Zaghloul, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)

7 Previous Clinical Trials

631 Total Patients Enrolled

Media Library

Deep Brain Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT01581580 — N/A

Parkinson's Disease Research Study Groups: treatment arm

Parkinson's Disease Clinical Trial 2023: Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT01581580 — N/A

Deep Brain Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01581580 — N/A

Frequently Asked Questions

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

What is the sample size of this investigative research?

"Yes, according to clinicaltrials.gov, this experiment is currently accepting participants. This particular trial was issued on August 17th 2011 and last updated December 1st 2022. The study requires 200 individuals from two medical research sites."

Answered by AI

Are there any vacancies still open to enrollees in this research study?

"According to the details posted on clinicaltrials.gov, this research endeavour is currently enrolling participants with recruitment starting as early as August 17th 2011 and last updated December 1st 2022."

Answered by AI