Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527573
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Effects of rTMS With Different Stimulation Spots in Patients With Disorders of Consciousness
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Targeting Anterior or Posterior Where is Better for DOC
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Disorders of consciousness are a state in which consciousness is affected by brain damage resulting in dysfunctions in alertness awareness and behavior Patients with disorders of consciousness can be categorized into coma unresponsive arousal syndromeUWS and minimally conscious statesMCS Common causes include craniocerebral trauma and non-craniocerebral trauma causes such as stroke and ischemic-hypoxic encephalopathy The number of patients with disorders of consciousness is rapidly increasing worldwide and is not only affecting the lives of individuals and their families but is becoming a serious public health threatTranscranial magnetic stimulation uses an electromagnetic pulse to induce focalised neural depolarisation and firing Repeated transcranial magnetic stimulation compared with single pulse transcranial magnetic stimulation can influence brain plasticity and cortical organisation through alterations of neuronal excitability and is now being used to improve consciousness and functional recovery in patients with disorders of consciousness However the optimization of TMS stimulation parameters has become one of the key factors affecting the therapeutic efficacy especially the choice of treatment location
MethodThis study is a randomized double-blind controlled trialAnd eighty-four patients are expected to be recruited and they will be randomly assigned in a 111 ratio to two test groups and one control group of 28 patients each Each patient receives a one-week period of repetitive transcranial magnetic stimulation at 10 Hz twice daily for a total of 14 treatments Primary and secondary evaluation indices will be performed at each baseline and after rTMS treatment Primary and secondary evaluating indicators will be performed at each baseline and after rTMS treatment Primary outcome will be determined as behavioral response to treatment as measured using the Coma Recovery Scale - Revised CRS-R Resting-state high-density EEG and TMS-EEG will be also recorded to investigate the neurophysiological correlates by rTMS
DiscussionThis study will contribute to the selection of therapeutic target locations for rTMS in patients with disorders of consciousness and has the potential to explore mechanisms of consciousness and to validate the role of rTMS parameter optimization in patients with disorders of consciousness using randomized controlled trials
MethodThis study is a randomized double-blind controlled trialAnd eighty-four patients are expected to be recruited and they will be randomly assigned in a 111 ratio to two test groups and one control group of 28 patients each Each patient receives a one-week period of repetitive transcranial magnetic stimulation at 10 Hz twice daily for a total of 14 treatments Primary and secondary evaluation indices will be performed at each baseline and after rTMS treatment Primary and secondary evaluating indicators will be performed at each baseline and after rTMS treatment Primary outcome will be determined as behavioral response to treatment as measured using the Coma Recovery Scale - Revised CRS-R Resting-state high-density EEG and TMS-EEG will be also recorded to investigate the neurophysiological correlates by rTMS
DiscussionThis study will contribute to the selection of therapeutic target locations for rTMS in patients with disorders of consciousness and has the potential to explore mechanisms of consciousness and to validate the role of rTMS parameter optimization in patients with disorders of consciousness using randomized controlled trials
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None