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NCT07914257Toborzás még nem indult

Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 3.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

The purpose of the study is to test whether low-level electric stimulation, called High Definition transcranial Direct Current Stimulation (HDtDCS), on the part of the brain (i.e., left inferior frontal gyrus) thought to aid in memory will improve verbal retrieval in multiple sclerosis patients. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
80 (tervezett)
Első benyújtás
2026. okt. 27.
Kezdés
2026. nov. 1.
Elsődleges befejezés
2028. szept. 1.
Fő szponzor
The University of Texas at Dallas
NCT-szám
NCT07914257

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 80
  • 2026. nov. 1. és az elsődleges befejezés (2028. szept. 1.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Head implant or skull defects/damage that would affect HDtDCS administration or EEG recording;
  • Medication Restrictions: Certain medications can temporarily change how your brain responds to electrical stimulation or affect EEG signals, and therefore are exclusionary: 1) Known medications that interact with tDCS efficacy: anti-convulsants, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole; 2) Medications that lower the seizure threshold; 3) Stimulant Medications (e.g., Adderall, Ritalin, often used for MS-related fatigue) cannot be taken during the course of the study; enrollment can be considered if the participant is willing to suspend use over the course of the study and suspension is coordinated with the prescribing physician); suspension must occur at least 3 days before any assessment session and must be maintained over the HDtDCS treatment phases of the study;
  • Steroid Medications (e.g., Prednisone, Decadron, IV Solu-Medrol, often used for MS relapses or inflammation treatment); If a participant has taken prescription steroid pills or received a steroid IV, they must wait at least 2 months (60 days) after your last dose before you can start tDCS treatments, although baseline testing will permissible within this 2-month waiting period.

Más betegség

  • A history of a neurological disorder, other than RRMS, including dementia of any type, epilepsy or other seizure disorders, brain tumor, present drug abuse, stroke, blood vessel abnormalities in the brain, Parkinson's disease, or - - Huntington's disease;
  • Epilepsy or other seizure disorder;
  • Unstable or uncontrolled psychiatric illness;
  • Serious or life-threatening diseases, including congestive heart failure, chronic obstructive pulmonary disease, or active malignancy;
  • Stroke;
  • Cardiac, neural, or medication implants that would affect HDtDCS administration or EEG recording;
  • Scalp skin condition like dermatitis, psoriasis, or eczema;
  • Cognitive impairment due to an issue other than RRMS;

Egyéb

  • Relapse or acute MS exacerbation during the two months (60 days) preceding the baseline testing, with re-evaluation for inclusion possible after the 60 days of stability;
  • Less than 3 months (90 days) on a stable dose of benzodiazepines or modaphinil/armodafinil;
  • Severe traumatic brain injury;
  • Unexplained episodes of loss of consciousness;
  • Suffering frequent headaches;
  • Brain tumor;
  • Use of brain medical device;
  • Vascular clip;
  • Current substance abuse, less than 1 year of discontinuation; Pregnancy;
  • Telephone-administered Montreal Cognitive Assessment (TMoCA) Score <19, unless accompanied by a legally authorized representative (LAR) to the consenting session;
  • Montreal Cognitive Assessment (MoCA) Score <23, unless accompanied by an LAR to all sessions and both the participant and LAR provide consent; Not being able to give informed consent, unless accompanied by an LAR to all sessions and both the participant and LAR provide consent, and with consent ability assessed with a set of comprehension questions regarding the study and consenting to participate and with MoCA criteria above;

Kiket keres a vizsgálat

  • Participants must be between the ages of 18 and 64;
  • Participants must have a diagnosis of relapsing-remitting multiple sclerosis (RRMS). A physician's note verifying RRMS will be required if they are a patient outside the UT Southwestern network;
  • Participants must have a validated memory deficit: Validation will be done via neuropsychological testing at the initial/baseline visit using the Semantic Object Retrieval Test (SORT), COWAT (letter and category fluency), Boston Naming Test (BNT), and Auditory Verbal Learning Test (AVLT); neuropsychological test score on at least one verbal retrieval assessment (COWAT, BNT, AVLT) of a T-score less than 40 or a verbal retrieval test that was greater than 1.0 SD below the average T-score on SORT;
  • Participants must be fluent in speaking and reading English because testing materials are not available in other languages.

Életkor a regiszterben: 18 év – 64 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Callier Clinical Researcher CenterRichardsonEgyesült ÁllamokIsmeretlen állapot

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