Sleep Disorder in Parkinson Disease and rTMS

NCT05599035 | Completed DMC

• 1 other identifier: sleep disorder in parkinson
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The crude prevalence rate of Parkinson's disease in Upper Egypt governorates ranging from 557-436/100,000 (Assiut and Qena governorates respectively) which was one of the highest prevalence of PD around the world .Parkinson's disease patients report having complaints of disrupted sleep anywhere from 60 to 98 %. This is one of the most common non-motor symptoms, and it is a substantial contributor to the diminished quality of life associated with Parkinson's disease. PD patients have poor sleep maintenance and fragmentation (Comella 2007, Khedr et al. 2013). Khedr et al (2013) found that; 78.6% out of 112 patients with PD had sleep disturbances with the commonest complaint being difficulty getting to sleep at night or staying asleep (46.4%) followed by vivid nightmares and night terrors (27.7%). In other studies, 80-90% of PD patients have had sleep difficulty with virtually all patients having symptoms at some time in the course of the disease .

Conditions

Sleep Disorder; Parkinson Disease

Keywords

sleep disorder Parkinson disease; rTMS

Outcome Measures

Primary Outcomes (2)

• Parkinson's disease sleep scale (PDSS)

  The PDSS is a visual analogue scale addressing 15 commonly reported symptoms associated with sleep disturbance overall quality of night's sleep (item 1); • sleep onset and maintenance insomnia (items 2 and 3); • nocturnal restlessness (items 4 and 5); • nocturnal psychosis (items 6 and 7) • nocturia (items 8 and 9); • nocturnal motor symptoms (items 10-13); • sleep refreshment (item 14); • daytime dozing (item 15).

  1 month

• polysomenography

  This polysomnography systematically monitored the electroencephalogram (EEG) (C3-A2, C4-A1), electrooculogram (EOG), electromyogram of the chin (EMG), electrocardiogram (EKG), body positions, nasal and oral airflow, thoracic and abdominal effort, limb movements, pulse oximetry, and snoring sound level.

  1 month

Secondary Outcomes (3)

• Beck Depression Inventory

  1 month

• Unified Parkinson's Disease Rating Scale (UPDRS)

  1 month

• Cognitive assessment using Montreal Cognitive assessment

  1 month

Study Arms (2)

1st group received active rTMS,

ACTIVE COMPARATOR

Active rTMS was applied using a figure-of-8 coil (7-cm diameter loop) positioned over the parietal area for ten sessions (10 trains, with frequency of stimulation 20-Hz, each lasting for 10 seconds with an inter-train interval of 30 seconds. The intensity of stimulation was set at 80% of the RMT for the first dorsal interosseous (FDI) of the contralateral hand with a total 2000 pulses for each hemisphere). Each patient received five sessions /week for two consecutive weeks with ten total sessions over the parietal area. The parietal region was determined according to the 10-20 system for electroencephalographic electrode positioning at P3 and P4, respectively.

Device: repititive transcranial magnetic stimulation

2nd group was the sham group

SHAM COMPARATOR

rTMS was applied using the same parameters, but with the coil edge was applied perpendicular to the scalp in the sagittal plane jut to reproduce the noise of the stimulation

Device: repititive transcranial magnetic stimulation

Interventions

repititive transcranial magnetic stimulation DEVICE

a figure-of-8 coil (7-cm diameter loop) positioned over the parietal area for ten sessions (10 trains, with frequency of stimulation 20-Hz, each lasting for 10 seconds with an inter-train interval of 30 seconds. The intensity of stimulation was set at 80% of the RMT for the first dorsal interosseous (FDI) of the contralateral hand with a total 2000 pulses for each parietal area.)

1st group received active rTMS,; 2nd group was the sham group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of PD was done according to UK Brain bank Criteria for diagnosis of PD. Out of them we selected only patients with sleep disturbance All patients fulfilled by Parkinson's disease sleep scale (PDSS).

You may not qualify if:

• Patients with PD with disturbed conscious level, severe cognitive impairment, psychosis, and medical problems such as (Renal failure, Liver cell Failure, Respiratory Failure, and endocrinal impairment), patients with other types of Parkinsonism as (Multisystem atrophy, supranuclear palsy, and encephalitic Parkinsonism) and patients had contraindication of magnetic stimulation (metallic piece, pacemaker, epilepsy) were also excluded from the study

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Eman Khedr

Asyut, 11517, Egypt

Location

Related Publications (7)

• Oerlemans WG, de Weerd AW. The prevalence of sleep disorders in patients with Parkinson's disease. A self-reported, community-based survey. Sleep Med. 2002 Mar;3(2):147-9. doi: 10.1016/s1389-9457(01)00127-7.

  PMID: 14592234 BACKGROUND

• Chaudhuri KR, Yates L, Martinez-Martin P. The non-motor symptom complex of Parkinson's disease: a comprehensive assessment is essential. Curr Neurol Neurosci Rep. 2005 Jul;5(4):275-83. doi: 10.1007/s11910-005-0072-6.

  PMID: 15987611 BACKGROUND

• Arias P, Vivas J, Grieve KL, Cudeiro J. Double-blind, randomized, placebo controlled trial on the effect of 10 days low-frequency rTMS over the vertex on sleep in Parkinson's disease. Sleep Med. 2010 Sep;11(8):759-65. doi: 10.1016/j.sleep.2010.05.003. Epub 2010 Jul 31.

  PMID: 20674489 BACKGROUND

• Khedr EM, Farweez HM, Islam H. Therapeutic effect of repetitive transcranial magnetic stimulation on motor function in Parkinson's disease patients. Eur J Neurol. 2003 Sep;10(5):567-72. doi: 10.1046/j.1468-1331.2003.00649.x.

  PMID: 12940840 BACKGROUND

• Khedr EM, Fawi G, Abbas MA, Mohammed TA, El-Fetoh NA, Attar GA, Zaki AF. Prevalence of Parkinsonism and Parkinson's disease in Qena governorate/Egypt: a cross-sectional community-based survey. Neurol Res. 2015 Jul;37(7):607-18. doi: 10.1179/1743132815Y.0000000020. Epub 2015 Mar 23.

  PMID: 25796953 BACKGROUND

• Khedr EM, Al Attar GS, Kandil MR, Kamel NF, Abo Elfetoh N, Ahmed MA. Epidemiological study and clinical profile of Parkinson's disease in the Assiut Governorate, Egypt: a community-based study. Neuroepidemiology. 2012;38(3):154-63. doi: 10.1159/000335701. Epub 2012 Mar 29.

  PMID: 22473384 BACKGROUND

• Khedr EM, El Fetoh NA, Khalifa H, Ahmed MA, El Beh KM. Prevalence of non motor features in a cohort of Parkinson's disease patients. Clin Neurol Neurosurg. 2013 Jun;115(6):673-7. doi: 10.1016/j.clineuro.2012.07.032. Epub 2012 Aug 16.

  PMID: 22902078 BACKGROUND

MeSH Terms

Conditions

Sleep Wake Disorders; Parkinson Disease

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Out of 45 PD patients, 30 patients had sleep disturbance and 6 out of them refused to be participated in the study . Group allocations (active or vs sham with ratio 2 (16 cases):1(8 cases) were placed in serially numbered closed envelopes.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: This study included 30 PD patients and 20 normal volunteers' age and sex matched that were recruited .The diagnosis of PD was done according to UK Brain bank Criteria for diagnosis of PD. Out of them we selected only patients with sleep disturbance according to Self-reported questionnaire for non-motor symptoms (sleep disturbance section; Question 23, 24, 25, 26 as follow 23-Difficulty getting to sleep at night or staying asleep at night 24. Intense, vivid dreams or frightening dreams. 25. Talking or moving about in your sleep as if you are 'acting out' a dream 26. Unpleasant sensations in your legs at night or while resting, and a feeling that you need to move.,) (NMSQuest) or frightening dreams All patients fulfilled by Parkinson's disease sleep scale (PDSS). Treatment was maintained constant during the trial. Each patient under levodopa (Sinemet 250/25; ½ table 3 times per day) and anticholinergic (cogenitol ½ table 3 times per day).

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 31, 2022
• Study Start: May 2, 2023
• Primary Completion: January 5, 2024
• Study Completion: February 4, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-01

Locations

EG (1)